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What changed in Penumbra Inc's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Penumbra Inc's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+320 added−286 removedSource: 10-K (2026-02-25) vs 10-K (2025-02-18)

Top changes in Penumbra Inc's 2025 10-K

320 paragraphs added · 286 removed · 249 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

66 edited+17 added−11 removed151 unchanged
Biggest changeFailure by manufacturers or by their suppliers to comply with applicable regulatory requirements can result in enforcement action by FDA or state authorities, which may include any of the following sanctions: • warning or untitled letters, fines, injunctions, consent decrees and civil penalties; • customer notifications, voluntary or mandatory recall or seizure of our products; • operating restrictions, partial suspension or total shutdown of production; • delay in processing submissions or applications for new products or modifications to existing products; • withdrawing approvals that have already been granted; and • criminal prosecution. 16 Table of Contents The Medical Device Reporting laws and regulations require us to provide information to FDA when we receive or otherwise become aware of information that reasonably suggests our device may have caused or contributed to a death or serious injury as well as a device malfunction that likely would cause or contribute to death or serious injury if the malfunction were to recur.
Biggest changeFailure by manufacturers or by their suppliers to comply with applicable regulatory requirements can result in enforcement action by FDA or state authorities, which may include any of the following sanctions: • warning or untitled letters, fines, injunctions, consent decrees and civil penalties; • customer notifications, voluntary or mandatory recall or seizure of our products; • operating restrictions, partial suspension or total shutdown of production; • delay in processing submissions or applications for new products or modifications to existing products; • withdrawing approvals that have already been granted; and • criminal prosecution.
Code of Federal Regulations (“CFR”), which requires manufacturers, including third-party manufacturers, to follow design, testing, control, documentation, and other quality assurance procedures during all aspects of the manufacturing process; • labeling regulations and prohibitions against product adulteration and misbranding (e.g., the promotion of products that do not have the appropriate market clearance or promotion for “off-label” uses), and other requirements related to promotional activities; • medical device reporting regulations, which require that manufacturers report to FDA if their device may have caused or contributed to a death or serious injury or if their device malfunctioned and the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur; • corrections and removal reporting regulations, which require that manufacturers report to FDA field corrections or removals if undertaken to reduce a risk to health posed by a device or to remedy a violation of the FD&C Act that may present a risk to health; and • post-market surveillance regulations, which apply to certain Class II or Class III devices when necessary to protect the public health or to provide additional safety and effectiveness data for the device.
Code of Federal Regulations, and which requires manufacturers, including third-party manufacturers, to follow design, testing, control, documentation, and other quality assurance procedures during all aspects of the manufacturing process; • labeling regulations and prohibitions against product adulteration and misbranding (e.g., the promotion of products that do not have the appropriate market clearance or promotion for “off-label” uses), and other requirements related to promotional activities; • medical device reporting regulations, which require that manufacturers report to FDA if their device may have caused or contributed to a death or serious injury or if their device malfunctioned and the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur; • corrections and removal reporting regulations, which require that manufacturers report to FDA field corrections or removals if undertaken to reduce a risk to health posed by a device or to remedy a violation of the FD&C Act that may present a risk to health; and • post-market surveillance regulations, which apply to certain Class II or Class III devices when necessary to protect the public health or to provide additional safety and effectiveness data for the device.
FDA can also impose sales, marketing or other restrictions on devices in order to assure that they are used in a safe and effective manner. 510(k) Clearance Pathway When a 510(k) clearance is required, a premarket notification must be submitted to FDA demonstrating that the proposed device is substantially equivalent to a predicate device, which is a previously cleared and legally marketed 510(k) device or a device that was in commercial distribution before May 28, 1976.
FDA can also impose sales, marketing or other restrictions on devices to assure they are used in a safe and effective manner. 510(k) Clearance Pathway When a 510(k) clearance is required, a premarket notification must be submitted to FDA demonstrating that the proposed device is substantially equivalent to a predicate device, which is a previously cleared and legally marketed 510(k) device or a device that was in commercial distribution before May 28, 1976.
Where possible, we seek second source suppliers or suppliers that have alternate manufacturing sites at which they could manufacture our parts. Sales and Marketing We sell our products directly in the United States, most of Europe, Canada and Australia, subject to required regulatory clearances and approvals. We have complemented our direct sales organization with distributors in most international markets.
Where possible, we seek second-source suppliers or suppliers that have alternate manufacturing sites at which they could manufacture our parts. Sales and Marketing We sell our products directly in the United States, most of Europe, Canada, Australia and Singapore, subject to required regulatory clearances and approvals. We have complemented our direct sales organization with distributors in most international markets.
Exit of Immersive Healthcare Business” to our consolidated financial statements in Part II, Item 8 of this Form 10-K. During the year ended December 31, 2024, we permanently ceased sales of our Immersive Healthcare products and related commercial operations.
Exit of Immersive Healthcare Business” to our consolidated financial statements in Part II, Item 8 of this Form 10-K. In addition, during the year ended December 31, 2024, we permanently ceased sales of our immersive healthcare products and related commercial operations.
Our team focuses on developing, manufacturing and marketing novel products for use by specialist physicians and healthcare providers to drive improved clinical and health outcomes. We believe that the cost-effectiveness of our products is attractive to our customers.
Our team focuses on developing, manufacturing and marketing novel products for use by specialist physicians and other healthcare providers to drive improved clinical and health outcomes. We believe that the cost-effectiveness of our products is attractive to our customers.
The Indigo System is comprised of four principal components: • Continuous Aspiration Mechanical Thrombectomy Catheters are robust, durable, trackable and suited for the peripheral and coronary anatomy. We have introduced multiple sizes of catheters for use in both the peripheral and coronary vasculature.
The Indigo System is comprised of four principal components: • Continuous Aspiration Mechanical Thrombectomy (CAT) Catheters are robust, durable, trackable and suited for the peripheral and coronary anatomy. We have introduced multiple sizes of catheters for use in both the peripheral and coronary vasculature.
The Ruby Coil System is used in a variety of clinical applications, including, but not limited to: • active extravasations, or the escape of blood into surrounding tissue; • selective embolization in patients with visceral aneurysms; • exclusion of branches prior to chemoembolization and radioembolization; • embolization in patients with gastrointestinal bleeding; 9 Table of Contents • embolization of branches prior to stent graft procedures; • procedures after stent grafting in patients with persistent type II endoleaks and sac enlargement; • treatment of patients with varicocele and pelvic congestion syndrome; • high-flow arterial venous malformations; • post trans intrahepatic shunt placement; • balloon retrograde transvenous obliteration; and • exclusion of hepatic branches prior to liver resection.
The Ruby Embolization Platform is used in a variety of clinical applications, including, but not limited to: • active extravasations, or the escape of blood into surrounding tissue; 9 Table of Contents • selective embolization in patients with visceral aneurysms; • exclusion of branches prior to chemoembolization and radioembolization; • embolization in patients with gastrointestinal bleeding; • embolization of branches prior to stent graft procedures; • procedures after stent grafting in patients with persistent type II endoleaks and sac enlargement; • treatment of patients with varicocele and pelvic congestion syndrome; • high-flow arterial venous malformations; • post trans intrahepatic shunt placement; • balloon retrograde transvenous obliteration; and • exclusion of hepatic branches prior to liver resection.
We compete with a number of manufacturers and distributors of neuro and vascular medical devices. Our most notable competitors are Boston Scientific, Inari Medical, Medtronic, Stryker, Terumo and several private companies. Most of these competitors are large, well-capitalized companies with longer operating histories and greater resources than we have.
We compete with a number of manufacturers and distributors of neuro and vascular medical devices. Our most notable competitors are Boston Scientific, Medtronic, Stryker (now including Inari Medical), Terumo and several private companies. Most of these competitors are large, well-capitalized companies with longer operating histories and greater resources than we have.
We have continued licensing the technology to certain of our products to our existing distribution partner in China pursuant to a series of licensing arrangements entered into in December 2020, February 2022, September 2023 and March 2024, which permit our partner to manufacture and commercialize such products in China in exchange for fixed payments upon the transfer of the distinct licensed technology and upon the provision of related regulatory support, as well as, in certain cases, royalty payments on downstream sales of the licensed products.
We license the technology to certain of our products to our existing distribution partner in China pursuant to a series of licensing arrangements entered into in December 2020, February 2022, September 2023 and March 2024, which permit our partner to manufacture and commercialize such products in China in exchange for fixed payments upon the transfer of the distinct licensed technology and upon the provision of related regulatory support, as well as, in certain cases, royalty payments on downstream sales of the licensed products.
We developed our proprietary aspiration source as a fully-integrated system specifically for mechanical thrombectomy by aspiration. Embolization and Access Products Peripheral Embolization Products Ruby Coil System The Ruby Coil System consists of detachable coils that are specifically designed for peripheral applications.
We developed our proprietary aspiration source as a fully-integrated system specifically for mechanical thrombectomy by aspiration. Embolization and Access Products Peripheral Embolization Products Ruby Embolization Platform The Ruby Embolization Platform consists of detachable coils that are specifically designed for peripheral applications.
Information related to the device, patient population, phase of investigation, study sites and investigators, and other aspects of the clinical trial is made public as part of the registration. 15 Table of Contents Ongoing Regulation by FDA Along with the requirement for device clearance or approval by FDA, there are additional obligations and regulations that must be followed.
Information related to the device, patient population, phase of investigation, study sites and investigators, and other aspects of the clinical trial is made public as part of the registration. Ongoing Regulation by FDA Along with the requirement for device clearance or approval by FDA, there are additional obligations and regulations that must be followed.
We use annual internal audits to ensure strong quality control practices. An internal, on-going staff training and education program contributes to our quality assurance program; training is documented and considered part of the employee evaluation process. We believe we have adequate supplies or sources of availability of raw materials necessary to meet our needs.
We use annual internal audits to ensure strong quality control practices. An internal, on-going staff training and education program contributes to our quality assurance program; training is documented and considered part of the employee evaluation process. 11 Table of Contents We believe we have adequate supplies or sources of availability of raw materials necessary to meet our needs.
This reporting requirement was expanded by the SUPPORT for Patients and Communities Act, which required manufacturers, beginning January 1, 2021, to report payments or other transfers of value to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives in addition to physicians and teaching hospitals.
This reporting requirement was expanded by the SUPPORT for Patients and Communities Act, which required manufacturers, beginning January 1, 2021, to report payments or other transfers of value to physician assistants, nurse practitioners, clinical nurse 18 Table of Contents specialists, certified registered nurse anesthetists, and certified nurse midwives in addition to physicians and teaching hospitals.
Our continued success depends on our ability to: • develop innovative, proprietary products that can cost-effectively address significant clinical needs; • continue to innovate and develop scientifically advanced technology; • obtain and maintain regulatory clearances or approvals; • demonstrate safety and efficacy in Penumbra-sponsored and third-party clinical trials and studies; • apply technology across product lines and markets; • attract and retain skilled research and development and sales personnel; and • cost-effectively manufacture and successfully market and sell products.
Our continued success depends on our ability to: • develop innovative, proprietary products that can cost-effectively address significant clinical needs; • continue to innovate and develop scientifically advanced technology; • obtain and maintain regulatory clearances or approvals; 13 Table of Contents • demonstrate safety and efficacy in Penumbra-sponsored and third-party clinical trials and studies; • apply technology across product lines and markets; • attract and retain skilled research and development and sales personnel; and • cost-effectively manufacture and successfully market and sell products.
Most Class I devices are classified as exempt from premarket notification under Section 510(k) of the FD&C Act, and therefore may be commercially distributed without obtaining 510(k) clearance from FDA. Class II devices are subject to both general controls and special controls to provide reasonable assurance of safety and effectiveness.
Most Class I devices and some Class II devices are exempt from premarket notification under Section 510(k) of the FD&C Act and therefore may be commercially distributed without obtaining 510(k) clearance from FDA. Class II devices are subject to both general controls and special controls to provide reasonable assurance of safety and effectiveness.
In addition, HIPAA and its implementing 18 Table of Contents regulations established uniform standards for certain covered entities, which are healthcare providers, health plans and healthcare clearinghouses, as well as their business associates, governing the conduct of specified electronic healthcare transactions and protecting the security and privacy of protected health information.
In addition, HIPAA and its implementing regulations established uniform standards for certain covered entities, which are healthcare providers, health plans and healthcare clearinghouses, as well as their business associates, governing the conduct of specified electronic healthcare transactions and protecting the security and privacy of protected health information.
The lease for the Salt Lake City warehouse expires in 2027, subject to our option to renew the lease for an additional five years. We also lease office and/or warehouse space in Germany, Italy, Brazil, Australia, Singapore, Japan, Hong Kong and Taiwan as of December 31, 2024.
The lease for the Salt Lake City warehouse expires in 2027, subject to our option to renew the lease for an additional five years. We also lease office and/or warehouse space in Germany, Italy, Poland, Brazil, Australia, Singapore, Japan, Hong Kong and Taiwan as of December 31, 2025.
Our ability to achieve market 12 Table of Contents acceptance or significant sales volume will depend in large part on the availability of coverage and the level of reimbursement for procedures performed using our products under healthcare payment systems in such markets.
Our ability to achieve market acceptance or significant sales volume will depend in large part on the availability of coverage and the level of reimbursement for procedures performed using our products under healthcare payment systems in such markets.
Growth is fostered through professional development and learning programs as well as practical experience leading projects or teams. Employees receive regular performance reviews to support their progress and development. • We recognize the benefits of a healthy workforce.
Growth is fostered through professional development and learning programs as well as practical experience leading projects or teams. Employees receive regular performance reviews to support their progress and development. 19 Table of Contents • We recognize the benefits of a healthy workforce.
Human Capital Resources As of December 31, 2024, we had approximately 4,500 employees worldwide. None of our U.S. employees are represented by a collective bargaining agreement. Some of our employees outside of the United States are subject to mandatory, industry-specific collective bargaining agreements or the protections of statutory works councils as required by local law.
Human Capital Resources As of December 31, 2025, we had approximately 4,700 employees worldwide. None of our U.S. employees are represented by a collective bargaining agreement. Some of our employees outside of the United States are subject to mandatory, industry-specific collective bargaining agreements or the protections of statutory works councils as required by local law.
Private payors vary in their coverage and payment policies. While some may look to coverage and payment by Medicare as a guide, most formulate their own coverage and payment policies. Some payors may deny reimbursement if they determine that the device used in a treatment was unnecessary, not cost-effective, or used for a non-approved indication.
Private payors vary in their coverage and payment policies. While some may look to coverage and payment by Medicare as a guide, most formulate their own coverage and payment policies. 12 Table of Contents Some payors may deny reimbursement if they determine that the device used in a treatment was unnecessary, not cost-effective, or used for a non-approved indication.
We participate in the Medical Device Single Audit Program (“MDSAP”) which allows for certification and review of compliance to standards and regulations required in the United States, Canada, Brazil, Australia, and Japan by a single auditing organization. We received our first MDSAP certification in 2018 and successfully completed our most recent recertification audit in 2024.
We participate in the Medical Device Single Audit Program (“MDSAP”) which allows for certification and review of compliance to standards and regulations required in the United States, Canada, Brazil, Australia, and Japan by a single auditing organization. We received our first MDSAP certification in 2018 and successfully completed our most recent surveillance audit in 2025.
In addition, FDA may conduct a preapproval inspection of the manufacturing facility to ensure compliance with the Quality System Regulation (“QSR”). FDA also may inspect one or more clinical sites to assure compliance with FDA’s regulations.
In addition, FDA may conduct a preapproval inspection of the manufacturing facility to ensure compliance with the Quality Management System Regulation (“QMSR”). FDA also may inspect one or more clinical sites to assure compliance with FDA’s regulations.
We are focused on developing strong relationships with specialist physicians and other healthcare providers and devote significant resources to training and educating 11 Table of Contents physicians and other healthcare providers in the use and benefits of our products.
We are focused on developing strong relationships with specialist physicians and other healthcare providers and devote significant resources to training and educating physicians and other healthcare providers in the use and benefits of our products.
We estimate there are approximately 800,000 annual PEs outside the U.S. and approximately 350,000 of them are massive or sub-massive, making them eligible for thrombectomy. • Deep Vein Thrombosis (“DVT”) : DVT occurs when a clot forms in a deep vein, usually in the leg and sometimes in the arm. Approximately 4 million DVTs occur annually worldwide.
We estimate there are approximately 800,000 annual PEs outside the U.S. and approximately 350,000 of them are high- or intermediate-risk, making them eligible for thrombectomy. • Deep Vein Thrombosis (“DVT”) : DVT occurs when a clot forms in a deep vein, usually in the leg and sometimes in the arm. Approximately 4 million DVTs occur annually worldwide.
Product Families Key Product Brands THROMBECTOMY Peripheral Indigo System Lightning Bolt CAT RX Neuro Penumbra System Penumbra RED, SENDit, JET, ACE, BMX, and MAX catheters 3D Revascularization Device Penumbra ENGINE and other components and accessories EMBOLIZATION & ACCESS Peripheral Embolization Ruby Coil System Ruby LP LANTERN POD (Penumbra Occlusion Device) Packing Coil Packing Coil LP Neuro Embolization Penumbra Coil 400 POD400 PAC400 Penumbra SMART COIL SwiftPAC Coil Access Neuron Neuron MAX BENCHMARK BMX DDC PX SLIM MIDWAY Neurosurgical Tools Artemis Neuro Evacuation Device Thrombectomy Products Our thrombectomy products fall into the following broad product families: Peripheral Thrombectomy Products Indigo System The Indigo System was designed for continuous, power aspiration of thrombus in the body, leveraging the success of the Penumbra System in ischemic stroke.
Product Families Key Product Brands THROMBECTOMY Peripheral Indigo System Lightning Flash Bolt CAT RX Neuro Penumbra System Penumbra RED, SENDit, JET, ACE, BMX, and MAX catheters 3D Revascularization Device Penumbra ENGINE and other components and accessories EMBOLIZATION & ACCESS Peripheral Embolization Ruby Embolization Platform Ruby LP Embolization Platform Ruby XL Embolization Platform LANTERN POD (Penumbra Occlusion Device) Packing Coil Packing Coil LP Neuro Embolization Penumbra Coil 400 POD400 PAC400 Penumbra SMART COIL SwiftPAC Coil SwiftSET Access Neuron Neuron MAX BENCHMARK BMX DDC PX SLIM MIDWAY Access25 Neurosurgical Tools Artemis Neuro Evacuation Device Thrombectomy Products Our thrombectomy products fall into the following broad product families: Peripheral Thrombectomy Products Indigo System The Indigo System is designed for continuous or modulated power aspiration of thrombus in the body, leveraging the success of the Penumbra System in ischemic stroke.
In 2024, direct sales accounted for approximately 87% of our revenue, with the balance generated by independent distributors that sell our products outside of the United States and by the arrangements with our partner in China, which include licensing royalty and distribution revenue.
In 2025, direct sales accounted for approximately 90% of our revenue, with the balance generated by independent distributors that sell our products outside of the United States and by the arrangements with our partner in China, which include licensing royalty and distribution revenue.
Special controls include performance standards, postmarket surveillance, patient registries, and guidance documents. A manufacturer may be required to submit to FDA a premarket notification requesting clearance to commercially distribute some Class II devices.
Special controls include performance standards, postmarket surveillance, patient registries, and guidance documents. A manufacturer may be required to 14 Table of Contents submit to FDA a premarket notification requesting clearance to commercially distribute some Class II devices.
We sell our products to healthcare providers primarily through our direct sales organization in the United States, most of Europe, Canada and Australia, as well as through distributors in select international markets. We generated revenue of $1,194.6 million, $1,058.5 million and $847.1 million for the years ended December 31, 2024, 2023 and 2022, respectively.
We sell our products to healthcare providers primarily through our direct sales organization in the United States, most of Europe, Canada, Australia and Singapore, as well as through distributors in select international markets. We generated revenue of $1,403.7 million, $1,194.6 million and $1,058.5 million for the years ended December 31, 2025, 2024 and 2023, respectively.
The office in Germany supports our direct sales operations in Europe as well as distributor relationships in Europe and the Middle East; the offices in Brazil, Australia, Singapore, Japan, Hong Kong and Taiwan support our sales and marketing efforts, including through our distribution partners, in Latin America, Australia and Southeast Asia, respectively; and the offices in Italy support the operations of Crossmed S.p.A., our wholly-owned subsidiary in Italy, including supporting our direct sales operations in Italy, San Marino, Vatican City, and Switzerland.
The offices in Germany and Poland support our direct sales and/or customer service operations in Europe as well as distributor relationships in Europe, the Middle East and Africa; the offices in Brazil, Australia, Singapore, Japan, Hong Kong and Taiwan support our sales and marketing efforts, including through our distribution partners, in Latin America, Australia and Southeast Asia, respectively; and the offices in Italy support the operations of Crossmed S.p.A., our wholly-owned subsidiary in Italy, including supporting our direct sales operations in Italy, San Marino, Vatican City, and Switzerland.
In 2021, our Quality Management System was first audited to the European Union Medical Devices Regulation in support of product CE marking, and we successfully completed our most recent recertification audit in 2024.
In 2021, our Quality Management System was first audited to the European Union Medical Devices Regulation in support of product CE marking, and we successfully completed our most recent surveillance audit in 2025.
The federal Anti-Kickback Statute is broad and 17 Table of Contents prohibits many arrangements and practices that are lawful in businesses outside of the healthcare industry.
The federal Anti-Kickback Statute is broad and prohibits many arrangements and practices that are lawful in businesses outside of the healthcare industry.
We provide employees at our Alameda campus with on-site restaurants that offer fresh food at discounted pricing for employees, and we maintain on-site fitness centers for employees at our Alameda and Roseville campuses. Employees in the United States are also eligible for a gym discount at a local commercial fitness chain.
We provide employees at our Alameda and Roseville campuses with fresh food options at discounted pricing for employees, and we maintain on-site fitness centers for employees at our Alameda and Roseville campuses. Employees in the United States are also eligible for a gym discount at a local commercial fitness chain.
These goals have produced a motivated, high-performing and inclusive employee population and leadership team: for example, as of December 31, 2024, nearly 50% of our employees are female, half of our senior management team are female, and more than 70% of our employee population in the United States are from a minority background.
These goals have produced a motivated, high-performing and inclusive employee population and leadership team: for example, as of December 31, 2025, more than 45% of our employees are female, approximately half of our senior management team are female, and more than 70% of our employee population in the United States are from a minority background.
We received ISO 13485:2016 certification of our Alameda facility in 2018 and successfully completed our most recent recertification audit in 2024. We received ISO 13485:2016 certification of our Roseville facility in 2020 and successfully completed our most recent recertification audit in 2024.
We received ISO 13485:2016 certification of our Alameda facility in 2018 and successfully completed our most recent surveillance audit in 2025. We received ISO 13485:2016 certification of our Roseville facility in 2020 and successfully completed our most recent surveillance audit in 2025.
We have updated our quality management system processes to meet the EU MDR requirements, which were successfully audited most recently in November 2024 by a Notified Body.
We have updated our quality management system processes to meet the EU MDR requirements, which were successfully audited most recently in October 2025 by our Notified Body.
We do not have any material licenses to any technology or intellectual property rights. As of December 31, 2024, we owned and/or had rights to 120 issued patents globally, of which 58 were U.S. patents.
We do not have any material licenses to any technology or intellectual property rights. As of December 31, 2025, we owned and/or had rights to 125 issued patents globally, of which 66 were U.S. patents.
The MIDWAY intermediate catheter family, launched in 2024, consists of MIDWAY43 and MIDWAY62. Inspired by our RED catheter technology, MIDWAY intermediate catheters are designed to deliver a variety of microcatheters and embolization devices such as flow diverters, intrasaccular devices, stent systems, and delivery microcatheters for embolization cases, through our BENCHMARK and BMX guide catheters.
Inspired by our RED catheter technology, MIDWAY intermediate catheters are designed to deliver a variety of microcatheters and embolization devices such as flow diverters, intrasaccular devices, stent systems, and delivery microcatheters for embolization cases, through our BENCHMARK and BMX guide catheters.
Special 510(k)s are appropriate for certain technological, design, and labeling changes to a device which necessitates a new 510(k) but where the method(s) to evaluate the change(s) are well-established, and whether the results can be sufficiently reviewed in a summary or risk analysis format. Abbreviated 510(k)s are for devices that conform to a recognized standard.
There are three types of 510(k)s: traditional, special and abbreviated. Special 510(k)s are appropriate for certain technological, design, and labeling changes to a device which necessitates a new 510(k) but where the method(s) to evaluate the change(s) are well-established, and whether the results can be sufficiently reviewed in a summary or risk analysis format.
Employee safety is also supported by an access control system at all facilities and a dedicated 24/7 Security team on the Alameda and Roseville campuses. We require all work-related injuries or illnesses to be reported.
Employee safety is also supported by an access control system at all facilities and a dedicated 24/7 Security team on the Alameda and Roseville campuses. We require all work-related injuries or illnesses to be reported. This information is reviewed monthly by our Safety Committee for analysis and trending.
In addition, we lease approximately 70,000 square feet of warehouse space in Livermore, California, and approximately 100,000 square feet of warehouse space in Salt Lake City, Utah. The leases for the Livermore warehouse spaces expire at various times in 2025 to 2028.
In addition, we lease approximately 51,000 square feet of warehouse space in Livermore, California, and approximately 100,000 square feet of warehouse space in Salt Lake City, Utah. The leases for the Livermore warehouse spaces expire in 2028.
We generated revenue of $815.5 million, $677.3 million and $511.1 million from our thrombectomy product category for the years ended December 31, 2024, 2023 and 2022, respectively. We generated revenue of $379.1 million, $381.2 million, and $336.0 million from our embolization and access product categories for the years ended December 31, 2024, 2023 and 2022, respectively.
We generated revenue of $947.9 million, $815.5 million and $677.3 million from our thrombectomy product category for the years ended December 31, 2025, 2024 and 2023, respectively. We generated revenue of $455.7 million, $379.1 million, and $381.2 million from our embolization and access product categories for the years ended December 31, 2025, 2024 and 2023, respectively.
Once submitted, FDA has 180 days to review a PMA application, although the review of an application generally occurs over a significantly longer period of time and can take up to several years.
By law, FDA has 180 days to review a PMA application once it has been accepted for filing, although the review of an application generally occurs over a significantly longer period of time and can take up to several years.
This represents an annual increase of 12.9% and 25.0%, respectively. We generated income from operations of $9.3 million, $73.6 million and $6.1 million for the years ended December 31, 2024, 2023 and 2022, respectively.
This represents an annual increase of 17.5% and 12.9%, respectively. We generated income from operations of $189.2 million, $9.3 million and $73.6 million for the years ended December 31, 2025, 2024 and 2023, respectively.
The special and abbreviated 510(k)s are intended to streamline review, and FDA intends to process special 510(k)s within 30 days of receipt.
Abbreviated 510(k)s are for devices that conform to a recognized standard. The special and abbreviated 510(k)s are intended to streamline review, and FDA intends to process special 510(k)s within 30 days of receipt.
The leases for these nine buildings expire at various times in 2036, subject to our option to renew certain leases for an additional five to fifteen years. We also lease approximately 210,000 square feet of office and manufacturing facilities in two buildings in Roseville, California.
We also lease approximately 260,000 square feet of office and manufacturing facilities in two buildings in Roseville, California. The leases for these two buildings expire in 2035, subject to our option to renew the leases for an additional five to ten years.
Included in the registered trademarks is a mark with our company name and logo. We also seek to protect our proprietary rights through a variety of other methods, including confidentiality agreements and proprietary information agreements with suppliers, employees, consultants and others who may have access to our proprietary information.
We also seek to protect our proprietary rights through a variety of other methods, including confidentiality agreements and proprietary information agreements with suppliers, employees, consultants and others who may have access to our proprietary information.
We have also submitted technical documentation supporting all of the device families we intend to CE Mark under EU MDR to our Notified body and obtained CE Mark approvals for the majority of our product families.
We have also submitted technical documentation supporting all of the device families we intend to CE Mark under EU MDR to our Notified body and obtained CE Mark approvals for all of our product families, allowing us to continue to supply our products to the markets in the region covered by EU MDR.
If FDA determines the device, or its intended use, is not substantially equivalent to a previously cleared device, the applicant may resubmit another 510(k) with new data, submit a De Novo Classification request, file a reclassification petition, or submit a PMA application for the device. There are three types of 510(k)s: traditional, special and abbreviated.
FDA may require further information, including clinical data, to make a determination of substantial equivalence. If FDA determines the device, or its intended use, is not substantially equivalent to a previously cleared device, the applicant may resubmit another 510(k) with new data, submit a De Novo Classification request, file a reclassification petition, or submit a PMA application for the device.
Additionally, the California Department of Health Services (“CDHS”) requires registration as a medical device manufacturer within the state. Therefore, FDA and the CDHS may inspect the registered facilities on a routine basis for compliance with the QSR. These regulations include requirements for the manufacturing of products and maintaining of related documentation with respect to manufacturing, testing, maintenance and control activities.
Additionally, the California Department of Health Services (“CDHS”) requires registration as a medical device manufacturer within the state. Therefore, FDA and the CDHS may inspect the registered facilities on a routine basis for compliance with the QMSR.
We believe these design features contribute to improved clinical outcomes and reduced procedure times. Penumbra System Reperfusion Catheters include the Penumbra RED, JET, ACE, BMX, and MAX families of catheters, designed to address a broad range of occlusions.
Penumbra System Reperfusion Catheters include the Penumbra RED, JET, ACE, BMX, and MAX families of catheters, designed to address a broad range of occlusions.
Some of our pending patent applications pertain to components and methods of use associated with currently commercialized products. Our pending patent applications may not result in issued patents and we can give no assurance that any patents that have issued or might issue in the future will protect our current or future products or provide us with any competitive advantage.
Our pending patent applications may not result in issued patents and we can give no assurance that any patents that have issued or might issue in the future will protect our current or future products or provide us with any competitive advantage. See the section titled “Risk Factors-Risks Related to Our Intellectual Property” in this Form 10-K for additional information.
The investigators must obtain patient informed consent, rigorously follow the investigational plan and study protocol, control the disposition of investigational devices, and comply with all reporting and recordkeeping requirements. Clinical trials for significant risk devices may not begin until the IDE application is approved by FDA and the appropriate institutional review boards (“IRBs”), at the clinical trial sites.
Clinical trials for significant risk devices may not begin until the IDE application is approved by FDA and the appropriate institutional review boards (“IRBs”), at the clinical trial sites.
Penumbra System Reperfusion Catheters are the cornerstone of the Penumbra System and are manufactured using a variety of proprietary processes and materials science innovations for use in revascularization of patients with acute ischemic stroke. The Penumbra System Reperfusion Catheters, powered by Penumbra ENGINE or Penumbra Pump MAX, are designed for trackability and to maximize thrombus removal force.
The Penumbra System is a fully integrated mechanical thrombectomy system consisting of reperfusion catheters and separators, the 3D Revascularization Device, aspiration tubing, and aspiration pump. Penumbra System Reperfusion Catheters are the cornerstone of the Penumbra System and are manufactured using a variety of proprietary processes and materials science innovations for use in revascularization of patients with acute ischemic stroke.
Manufacturers are subject to regular QSR inspections in connection with the manufacture of medical devices at registered facilities. Further, FDA requires compliance with various labeling regulations.
These 16 Table of Contents regulations include requirements for the manufacturing of products and maintaining of related documentation with respect to manufacturing, testing, maintenance and control activities. Manufacturers are subject to regular QMSR inspections in connection with the manufacture of medical devices at registered facilities. Further, FDA requires compliance with various labeling regulations.
In 2024, we launched Lightning Flash 2.0, our next generation technology featuring advanced Lightning Flash algorithms, designed for increased efficiency and sensitivity to thrombus and blood flow. Neuro Thrombectomy Products Our Penumbra System brand of products offers a form of mechanical thrombectomy used by specialist physicians to revascularize blood vessels that are blocked by clots in the intracranial vasculature.
Neuro Thrombectomy Products Our Penumbra System brand of products offers a form of mechanical thrombectomy used by specialist physicians to revascularize blood vessels that are blocked by clots in the intracranial vasculature. These products are aspiration-based.
The BENCHMARK also is available pre-packaged with a Select catheter to obviate the need for a neurovascular guide catheter exchange, which may reduce the number of devices needed per procedure and shorten procedure times. 10 Table of Contents The BENCHMARK family includes our BENCHMARK BMX Access System, which provides a larger internal diameter without increasing the outer diameter of the delivery catheter, enabling more working room for all neurovascular procedures while maintaining the same size access site as our Neuron MAX.
The BENCHMARK family includes our BENCHMARK BMX Access System, which provides a larger internal diameter without increasing the outer diameter of the delivery catheter, enabling more working room for all neurovascular procedures while maintaining the same size access site as our Neuron MAX. The MIDWAY intermediate catheter family, launched in 2024, consists of MIDWAY43 and MIDWAY62.
We have successfully developed, obtained regulatory clearance or approval for, and introduced products into the thrombectomy market since 2007, access market since 2008, embolization market since 2011, and neurosurgical market since 2014, and operated in the immersive healthcare market from 2020 until September 2024.
Since our founding in 2004, we have invested heavily in our product development and commercial expansion that has established the foundation of our global organization. We have successfully developed, obtained regulatory clearance or approval for, and introduced products into the thrombectomy market since 2007, access market since 2008, embolization market since 2011, and neurosurgical market since 2014.
See the section titled “Risk Factors-Risks Related to Our Intellectual Property” in this Form 10-K for additional information. Additionally, we own or have rights to trademarks or trade names that are used in our business and in conjunction with the sale of our products, including 45 U.S. trademark registrations and 225 foreign trademark registrations as of December 31, 2024.
Additionally, we own or have rights to trademarks or trade names that are used in our business and in conjunction with the sale of our products, including 46 U.S. trademark registrations and 235 foreign trademark registrations as of December 31, 2025. Included in the registered trademarks is a mark with our company name and logo.
Modifications to the cleared or approved products may require a new regulatory submission in all major markets. The regulatory requirements, and the review time, vary significantly from country to country. Fraud and Abuse and Other Healthcare Regulation Anti-Kickback Statute We are subject to various federal and state healthcare laws, including, but not limited to, anti-kickback laws.
Fraud and Abuse and Other Healthcare Regulation Anti-Kickback Statute We are subject to various federal and state healthcare laws, including, but not limited to, anti-kickback laws.
Thirty-seven of our issued patents, which relate to components of the Penumbra Coil 400, Ruby Coil System and Smart Coil System, are currently expected to expire between 2029 and 2037. Eighteen patents pertaining to the 3D Revascularization Device are projected to expire between 2032 and 2034.
As of December 31, 2025, we owned and/or had rights to 49 pending patent applications, of which 21 were patent applications pending in the United States. Thirty-seven of our issued patents, which relate to components of the Penumbra Coil 400, Ruby Embolization Platform and Smart Coil System, are currently expected to expire between 2029 and 2037.
This information is reviewed monthly by our Safety Committee for analysis and trending. 19 Table of Contents Facilities We maintain approximately 610,000 square feet of office, research and development, manufacturing and administrative facilities in nine buildings at our campus in Alameda, California as of December 31, 2024.
Facilities We maintain approximately 610,000 square feet of office, research and development, manufacturing and administrative facilities in nine buildings at our campus in Alameda, California as of December 31, 2025. The leases for these nine buildings expire at various times in 2036, subject to our option to renew certain leases for an additional five to fifteen years.
These include: • establishment registration and device listing; • QSR per 21 CFR Part 820 of U.S.
These include: • establishment registration and device listing; • QMSR, which became effective on February 2, 2026 and amended the requirements of the Quality System Regulation under 21 CFR Part 820 of U.S.
The length and volume of the coil are intended to reduce the total number of coils needed in a procedure. Access Products The Neuron family of guide catheters and the Penumbra distal delivery catheters (“DDC”) enable many endovascular procedures in the tortuous anatomy of the neurovasculature.
These attributes make it well-suited for a variety of neurovascular conditions, including intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. Access Products The Neuron family of guide catheters and the Penumbra distal delivery catheters (“DDC”) enable many endovascular procedures in the tortuous anatomy of the neurovasculature.
We also warehouse and distribute finished products to our international customers utilizing third-party logistics providers in the Netherlands and Australia. Legal Proceedings From time to time, we are subject to claims and assessments in the ordinary course of business.
We also warehouse and distribute finished products to our international customers utilizing third-party logistics providers in the Netherlands and Australia. During the year ended December 31, 2025, we entered into agreements to acquire property in Costa Rica and construct a manufacturing facility and warehouse for the production of medical devices. Refer to Note “5.
Removed
Since our founding in 2004, we have had a strong track record of organic product development and commercial expansion that has established the foundation of our global organization.
Added
There were no impairment or other charges in connection with the wind down and exit of our immersive healthcare business during the year ended December 31, 2025. On January 14, 2026, we entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Boston Scientific Corporation, a Delaware corporation, and Pinehurst Merger Sub, Inc.
Removed
Our results for the year ended December 31, 2022 were impacted by the COVID-19 pandemic, which impacted the performance of certain elective and semi-elective medical procedures, which were deferred to provide resources to fight the pandemic, as well as impacted global supply chains and labor markets, resulting in cost inflation and raw material supply constraints.
Added
(“Merger Sub”), a Delaware corporation and a wholly owned subsidiary of Boston Scientific Corporation, pursuant to which Boston Scientific Corporation has agreed to acquire us in a transaction (the “Merger”) reflecting an enterprise value of approximately $14.5 billion.
Removed
While the impact of the pandemic has subsided due to the development and widespread availability of vaccines for COVID-19, we will continue to prioritize the health and safety of our employees and to operate under any protocols mandated by local and state authorities. 5 Table of Contents Our Markets We concentrate on improving treatment outcomes for patients with certain forms of vascular disease.
Added
Under the terms of the Merger Agreement, which has been approved by the board of directors of each of the Company and Boston Scientific Corporation, the transaction values each share of our common stock at $374 per share, with our stockholders having the right to elect, for each share of our common stock held by them, to receive $374 in cash or 3.8721 shares of Boston Scientific Corporation’s common stock (valued at $374 based on the volume weighted average price of Boston Scientific Corporation’s common stock over the 10 trading days ending January 13, 2026), subject to proration, so that the total transaction consideration is paid approximately 73% in cash and approximately 27% in shares of Boston Scientific Corporation’s common stock.
Removed
These products are aspiration-based. The Penumbra System is a fully integrated mechanical thrombectomy system consisting of reperfusion catheters and separators, the 3D Revascularization Device, aspiration tubing, and aspiration pump.
Added
The Merger is expected to close by the end of 2026, subject to customary closing conditions, including approval by our stockholders and regulatory approvals. See Note “20.
Removed
As of December 31, 2024, we owned and/or had rights to 55 pending patent applications, of which 29 were patent applications 13 Table of Contents pending in the United States.
Added
Subsequent Events” to our consolidated financial statements in Part II, Item 8 of this Form 10-K for more information. 5 Table of Contents Our Markets We concentrate on improving treatment outcomes for patients with certain forms of vascular disease.
Removed
Subject to payment of required maintenance fees, annuities and other charges, 16 of our issued patents are currently expected to expire between 2025 and 2026; 13 of these patents relate to components of the Penumbra System and the Indigo System.
Added
In 2024, we launched Lightning Flash 2.0, designed for increased efficiency and sensitivity to thrombus and blood flow, and in 2025 we launched Lightning Flash 3.0, our next generation technology featuring advanced Lightning Flash algorithms designed for enhanced clot detection capabilities with increased sensitivity to thrombus and blood and enlarged tubing coupled with an automated backflush feature tailored for large thrombus burdens and to reduce friction from aspirated thrombus.
Removed
FDA may require further information, including clinical data, to make a determination of substantial 14 Table of Contents equivalence.
Added
In addition, in 2025 we launched Lightning Bolt 12 and Lightning Bolt 6X with TraX, our latest CAVT technology involving modulated aspiration, designed to provide even faster clot removal and rapidly restore blood flow, as well as allow physicians to reach and address smaller vessels.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeIn addition, we are subject to Section 203 of the Delaware General Corporation Law, which may have an anti-takeover effect with respect to transactions not approved in advance by our board of directors, including discouraging takeover attempts that could have resulted in a premium over the market price for shares of our common stock. 42 Table of Contents These provisions apply even if a takeover offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that our board of directors determines is not in our and our stockholders’ best interests and could also affect the price that some investors are willing to pay for our common stock.
Biggest changeIn addition, we are subject to Section 203 of the Delaware General Corporation Law, which may have an anti-takeover effect with respect to transactions not approved in advance by our board of directors, including discouraging takeover attempts that could have resulted in a premium over the market price for shares of our common stock.
Any such claim could also force use to do one or more of the following: • incur substantial monetary liability for infringement or other violations of intellectual property rights, which we may have to pay if a court decides that the product or technology at issue infringes or violates the third party’s rights, and if the court finds that the infringement was willful, we could be ordered to pay treble damages and the third party’s attorneys’ fees; • pay substantial damages to our customers or end users to discontinue use or replace infringing technology with non-infringing technology; • stop manufacturing, selling, using, exporting or licensing the product or technology incorporating the allegedly infringing technology or stop incorporating the allegedly infringing technology into such product or technology; • obtain from the owner of the infringed intellectual property right a license, which may require us to pay substantial upfront fees or royalties to sell or use the relevant technology and which may not be available on commercially reasonable terms, or at all; • redesign our products and technology so they do not infringe or violate the third party’s intellectual property rights, which may not be possible or may require substantial monetary expenditures and time; • enter into cross-licenses with our competitors, which could weaken our overall intellectual property position; • lose the opportunity to license our technology to others or to collect royalty payments based upon successful protection and assertion of our intellectual property against others; • find alternative suppliers for non-infringing products and technologies, which could be costly and create significant delay; or • relinquish rights associated with one or more of our patent claims, if our claims are held invalid or otherwise unenforceable.
Any such claim could also force use to do one or more of the following: • incur substantial monetary liability for infringement or other violations of intellectual property rights, which we may have to pay if a court decides that the product or technology at issue infringes or violates the third party’s 38 Table of Contents rights, and if the court finds that the infringement was willful, we could be ordered to pay treble damages and the third party’s attorneys’ fees; • pay substantial damages to our customers or end users to discontinue use or replace infringing technology with non-infringing technology; • stop manufacturing, selling, using, exporting or licensing the product or technology incorporating the allegedly infringing technology or stop incorporating the allegedly infringing technology into such product or technology; • obtain from the owner of the infringed intellectual property right a license, which may require us to pay substantial upfront fees or royalties to sell or use the relevant technology and which may not be available on commercially reasonable terms, or at all; • redesign our products and technology so they do not infringe or violate the third party’s intellectual property rights, which may not be possible or may require substantial monetary expenditures and time; • enter into cross-licenses with our competitors, which could weaken our overall intellectual property position; • lose the opportunity to license our technology to others or to collect royalty payments based upon successful protection and assertion of our intellectual property against others; • find alternative suppliers for non-infringing products and technologies, which could be costly and create significant delay; or • relinquish rights associated with one or more of our patent claims, if our claims are held invalid or otherwise unenforceable.
A person or entity does not need to have actual knowledge of these statutes or specific intent to violate them; • HIPAA, as amended by HITECH, and their respective implementing regulations, which impose requirements on certain covered healthcare providers, health plans and healthcare clearinghouses as well as their business associates that perform services for them that involve individually identifiable health information, relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization, including mandatory contractual terms as well as directly applicable privacy and security standards and requirements; • the federal physician sunshine requirements under the Affordable Care Act, which require certain manufacturers of drugs, devices, biologics, and medical supplies to report annually to CMS information related to payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), teaching hospitals, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives, and ownership and investment interests held by physicians and their immediate family members; and • state and foreign law equivalents of each of the above federal laws, such as foreign and state anti-kickback, anti-benefit and false claims laws, as well as state and foreign laws and regulations governing interactions with healthcare professionals and requiring disclosure of payments and interactions with healthcare professionals and state and foreign laws governing the privacy and security of health information in certain circumstances.
A person or entity does not need to have actual knowledge of these statutes or specific intent to violate them; • HIPAA, as amended by HITECH, and their respective implementing regulations, which impose requirements on certain covered healthcare providers, health plans and healthcare clearinghouses as well as their business associates that perform services for them that involve individually identifiable health information, relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization, including mandatory contractual terms as well as directly applicable privacy and security standards and requirements; • the federal physician sunshine requirements under the Affordable Care Act, which require certain manufacturers of drugs, devices, biologics, and medical supplies to report annually to CMS information related to payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), teaching hospitals, physician assistants, nurse practitioners, clinical nurse specialists, certified 35 Table of Contents registered nurse anesthetists, and certified nurse midwives, and ownership and investment interests held by physicians and their immediate family members; and • state and foreign law equivalents of each of the above federal laws, such as foreign and state anti-kickback, anti-benefit and false claims laws, as well as state and foreign laws and regulations governing interactions with healthcare professionals and requiring disclosure of payments and interactions with healthcare professionals and state and foreign laws governing the privacy and security of health information in certain circumstances.
This revenue and related operations will continue to be subject to the risks and challenges associated with international operations, including: • reliance on distributors; • varying coverage and reimbursement policies, processes and procedures; • pricing impacts due to national and regional tenders, including value-based procurement practices and government-imposed payback provisions; • difficulties in staffing and managing international operations from which sales are conducted; • difficulties in penetrating markets in which our competitors’ products or alternative procedures that do not use our products are more established; • reduced protection for intellectual property rights in some countries; • export licensing requirements or restrictions, trade regulations and foreign tax laws; • fluctuating foreign currency exchange rates; • foreign certification, regulatory requirements and legal requirements; • lengthy payment cycles and difficulty in collecting accounts receivable; • customs clearance and shipping delays; • reliance on third-party logistics providers who warehouse and distribute finished products to our international customers; • pricing pressure in international markets; • political and economic instability; 27 Table of Contents • preference for locally produced products; • higher incidence of corruption or unethical business practices; and • events resulting in negative impacts to, or uncertainty regarding, global trade, such as the reversal or renegotiation of international trade agreements and partnerships or the imposition of tariffs.
This revenue and related operations will continue to be subject to the risks and challenges associated with international operations, including: • reliance on distributors; • varying coverage and reimbursement policies, processes and procedures; • pricing impacts due to national and regional tenders, including value-based procurement practices and government-imposed payback provisions; • difficulties in staffing and managing international operations from which sales are conducted; • difficulties in penetrating markets in which our competitors’ products or alternative procedures that do not use our products are more established; • reduced protection for intellectual property rights in some countries; • export licensing requirements or restrictions, trade regulations and foreign tax laws; • fluctuating foreign currency exchange rates; • foreign certification, regulatory requirements and legal requirements; • lengthy payment cycles and difficulty in collecting accounts receivable; • customs clearance and shipping delays; • reliance on third-party logistics providers who warehouse and distribute finished products to our international customers; • pricing pressure in international markets; • political and economic instability; • preference for locally produced products; • higher incidence of corruption or unethical business practices; and • events resulting in negative impacts to, or uncertainty regarding, global trade, such as the reversal or renegotiation of international trade agreements and partnerships or the imposition of tariffs.
Factors that could cause fluctuations in the market price of our common stock include the following: • price and volume fluctuations in the overall stock market from time to time; • volatility in the market prices and trading volumes of medical device company stocks; • changes in operating performance and stock market valuations of other medical device companies generally, or those in our industry in particular; • sales of shares of our common stock by us or our stockholders; • failure of securities analysts to maintain coverage of us, changes in financial estimates by securities analysts who follow our company, or our failure to meet these estimates or the expectations of investors; • the financial projections we may provide to the public, any changes in those projections or our failure to meet those projections; • announcements by us or our competitors of new products or services; • the public’s reaction to our press releases, other public announcements and filings with the SEC; • rumors and market speculation involving us or other companies in our industry; • actual or anticipated changes in our results of operations or fluctuations in our results of operations; • actual or anticipated developments in our business, our competitors’ businesses or the competitive landscape generally; • litigation involving us, our industry or both, or investigations by regulators into our operations or those of our competitors; • developments or disputes concerning our intellectual property or other proprietary rights; • announced or completed acquisitions of businesses or technologies by us or our competitors; • new laws or regulations or new interpretations of existing laws or regulations applicable to our business; • changes in accounting standards, policies, guidelines, interpretations or principles; • any significant change in our management; and • general economic conditions and slow or negative growth of our markets.
Factors that could cause fluctuations in the market price of our common stock include the following: • price and volume fluctuations in the overall stock market from time to time; • volatility in the market prices and trading volumes of medical device company stocks; • changes in operating performance and stock market valuations of other medical device companies generally, or those in our industry in particular; • sales of shares of our common stock by us or our stockholders; • failure of securities analysts to maintain coverage of us, changes in financial estimates by securities analysts who follow our company, or our failure to meet these estimates or the expectations of investors; • the financial projections we may provide to the public, any changes in those projections or our failure to meet those projections; • announcements by us or our competitors of new products or services; • the public’s reaction to our press releases, other public announcements and filings with the SEC; • rumors and market speculation involving us or other companies in our industry; • actual or anticipated changes in our results of operations or fluctuations in our results of operations; 42 Table of Contents • actual or anticipated developments in our business, our competitors’ businesses or the competitive landscape generally; • litigation involving us, our industry or both, or investigations by regulators into our operations or those of our competitors; • developments or disputes concerning our intellectual property or other proprietary rights; • announced or completed acquisitions of businesses or technologies by us or our competitors; • new laws or regulations or new interpretations of existing laws or regulations applicable to our business; • changes in accounting standards, policies, guidelines, interpretations or principles; • any significant change in our management; and • general economic conditions and slow or negative growth of our markets.
We believe that our future success is highly dependent on the contributions of our executive officers, particularly Adam Elsesser, our chief executive officer and president, as well as our ability to attract and retain highly skilled and experienced sales and marketing, technical and other personnel in the United States and in international markets.
We believe that our future success is highly dependent on the contributions of our executive officers, particularly Adam Elsesser, our chief executive officer, as well as our ability to attract and retain highly skilled and experienced sales and marketing, technical and other personnel in the United States and in international markets.
The types of situations in which we may become a party to such litigation or proceedings include: • we or our collaborators may initiate litigation or other proceedings against third parties seeking to invalidate the patents held by those third parties or to obtain a judgment that our products or processes do not infringe those third parties’ patents; • we or our collaborators may participate at substantial cost in International Trade Commission proceedings to abate importation of products that would compete unfairly with our products; 36 Table of Contents • if our competitors file patent applications that claim technology also claimed by us or our licensors, we or our licensors may be required to participate in interference, derivation or opposition proceedings to determine the priority of invention, which could jeopardize our patent rights and potentially provide a third party with a dominant patent position; • if third parties initiate litigation claiming that our processes or products infringe their patent or other intellectual property rights, we and our collaborators will need to defend against such proceedings; • if third parties initiate litigation or other proceedings seeking to invalidate patents owned by or licensed to us or to obtain a declaratory judgment that their product or technology does not infringe our patents or patents licensed to us, we will need to defend against such proceedings; • we may be subject to ownership disputes relating to intellectual property, including disputes arising from conflicting obligations of consultants or others who are involved in developing our products; and • if a license to necessary technology is terminated, the licensor may initiate litigation claiming that our processes or products infringe or misappropriate their patent or other intellectual property rights and/or that we breached our obligations under the license agreement, and we and our collaborators would need to defend against such proceedings.
The types of situations in which we may become a party to such litigation or proceedings include: • we or our collaborators may initiate litigation or other proceedings against third parties seeking to invalidate the patents held by those third parties or to obtain a judgment that our products or processes do not infringe those third parties’ patents; • we or our collaborators may participate at substantial cost in International Trade Commission proceedings to abate importation of products that would compete unfairly with our products; • if our competitors file patent applications that claim technology also claimed by us or our licensors, we or our licensors may be required to participate in interference, derivation or opposition proceedings to determine the priority of invention, which could jeopardize our patent rights and potentially provide a third party with a dominant patent position; • if third parties initiate litigation claiming that our processes or products infringe their patent or other intellectual property rights, we and our collaborators will need to defend against such proceedings; • if third parties initiate litigation or other proceedings seeking to invalidate patents owned by or licensed to us or to obtain a declaratory judgment that their product or technology does not infringe our patents or patents licensed to us, we will need to defend against such proceedings; • we may be subject to ownership disputes relating to intellectual property, including disputes arising from conflicting obligations of consultants or others who are involved in developing our products; and • if a license to necessary technology is terminated, the licensor may initiate litigation claiming that our processes or products infringe or misappropriate their patent or other intellectual property rights and/or that we breached our obligations under the license agreement, and we and our collaborators would need to defend against such proceedings.
Our second amended and restated bylaws designate the state courts located within the state of Delaware (or if no state court located within Delaware has jurisdiction, the federal district court for the District of Delaware), in all cases subject to the court’s having personal jurisdiction over the indispensable parties named as defendants, as the exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a claim of a breach of fiduciary duty; any action asserting a claim against us arising pursuant to the Delaware General Corporation Law, our restated certificate of incorporation or our second amended and restated bylaws; or any action asserting a claim against us that is governed by the internal affairs doctrine.
Our third amended and restated bylaws designate the state courts located within the state of Delaware (or if no state court located within Delaware has jurisdiction, the federal district court for the District of Delaware), in all cases subject to the court’s having personal jurisdiction over the indispensable parties named as defendants, as the exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a claim of a breach of fiduciary duty; any action asserting a claim against us arising pursuant to the Delaware General Corporation Law, our amended and restated certificate of incorporation or our third amended and restated bylaws; or any action asserting a claim against us that is governed by the internal affairs doctrine.
If the information we rely upon to run our businesses were to be found to be inaccurate or unreliable, if we fail to maintain or protect our information technology systems and data integrity effectively, if we fail to develop and implement new or upgraded systems to meet our business needs in a timely manner, or if we fail to anticipate, plan for or manage significant disruptions to these systems, our competitive position could be harmed, we could have operational disruptions, we could lose existing customers, have difficulty preventing, detecting, and controlling fraud, have disputes with customers, specialist 30 Table of Contents physicians and other healthcare providers, have regulatory sanctions or penalties imposed or other legal problems, incur increased operating and administrative expenses, lose revenues as a result of a data privacy breach or theft of intellectual property or suffer other adverse consequences, any of which could have a material adverse effect on our business, results of operations, financial condition or cash flows.
If the information we rely upon to run our businesses were to be found to be inaccurate or unreliable, if we fail to maintain or protect our information technology systems and data integrity effectively, if we fail to develop and implement new or upgraded systems to meet our business needs in a timely manner, or if we fail to anticipate, plan for or manage significant disruptions to these systems, our competitive position could be harmed, we could have operational disruptions, we could lose existing customers, have difficulty preventing, detecting, and controlling fraud, have disputes with customers, specialist physicians and other healthcare providers, have regulatory sanctions or penalties imposed or other legal problems, incur increased operating and administrative expenses, lose revenues as a result of a data privacy breach or theft of intellectual property or suffer other adverse consequences, any of which could have a material adverse effect on our business, results of operations, financial condition or cash flows.
A person or entity does not need to have actual knowledge of this statute or specific intent to violate it; 33 Table of Contents • federal civil and criminal false claims laws and civil monetary penalty laws, including civil whistleblower or qui tam actions, that prohibit, among other things, knowingly presenting, or causing to be presented, claims for payment or approval to the federal government that are false or fraudulent, knowingly making a false statement material to an obligation to pay or transmit money or property to the federal government or knowingly concealing or knowingly and improperly avoiding or decreasing an obligation to pay or transmit money or property to the federal government; • HIPAA, which created federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters.
A person or entity does not need to have actual knowledge of this statute or specific intent to violate it; • federal civil and criminal false claims laws and civil monetary penalty laws, including civil whistleblower or qui tam actions, that prohibit, among other things, knowingly presenting, or causing to be presented, claims for payment or approval to the federal government that are false or fraudulent, knowingly making a false statement material to an obligation to pay or transmit money or property to the federal government or knowingly concealing or knowingly and improperly avoiding or decreasing an obligation to pay or transmit money or property to the federal government; • HIPAA, which created federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters.
A number of factors over which we have limited or no control may contribute to fluctuations in our financial results, such as: • variations in revenue due to the unavailability of specialist physicians who use our products during certain times of the year, such as those periods when there are major conferences on conditions they treat or those periods when high volume users of our products take time off of work; • positive or negative media coverage of our products or the procedures or products of our competitors or our industry; • publication of clinical trial results or studies by us or our competitors; • changes in our sales process due to industry changes, such as changes in the stroke care pathway; • delays in receipt of anticipated purchase orders; • delays in customers receiving products; • performance of our independent distributors; • our ability to obtain further regulatory clearances or approvals; • the timing of product development and clinical trial activities, including the pace of enrollment; • delays in, or failure of, product and component deliveries by our suppliers; • changes in reimbursement policies or levels; • the number of procedures performed in any given period using our products, which can sometimes vary significantly between periods; • customer response to the introduction of new products or alternative treatments, and the degree to we which we are effective in transitioning customers to our products; and • fluctuations in foreign currency.
A number of factors over which we have limited or no control may contribute to fluctuations in our financial results, such as: • variations in revenue due to the unavailability of specialist physicians who use our products during certain times of the year, such as those periods when there are major conferences on conditions they treat or those periods when high volume users of our products take time off of work; • positive or negative media coverage of our products or the procedures or products of our competitors or our industry; • publication of clinical trial results or studies by us or our competitors; • changes in our sales process due to industry changes, such as changes in the stroke care pathway; 45 Table of Contents • delays in receipt of anticipated purchase orders; • delays in customers receiving products; • performance of our independent distributors; • our ability to obtain further regulatory clearances or approvals; • the timing of product development and clinical trial activities, including the pace of enrollment; • delays in, or failure of, product and component deliveries by our suppliers; • changes in reimbursement policies or levels; • the number of procedures performed in any given period using our products, which can sometimes vary significantly between periods; • customer response to the introduction of new products or alternative treatments, and the degree to which we are effective in transitioning customers to our products; and • fluctuations in foreign currency exchange rates.
Failure to comply with regulatory requirements or the discovery of previously unknown problems with a product or manufacturer could result in fines, delays or suspensions of regulatory approvals or clearances, seizures or recalls of products (with the attendant expenses and adverse competitive impact), the banning of a particular device, an order to replace or refund the cost of any device previously manufactured or distributed, operating restrictions and criminal prosecution, as well as decreased sales as a result of negative publicity and product liability claims, all of which could have a material adverse effect on our business, results of operation, financial condition or cash flows.
Failure to comply with regulatory requirements or the discovery of previously unknown problems with a product or manufacturer could result in fines, delays or suspensions of regulatory approvals or clearances, seizures or recalls of products (with the attendant expenses and adverse 33 Table of Contents competitive impact), the banning of a particular device, an order to replace or refund the cost of any device previously manufactured or distributed, operating restrictions and criminal prosecution, as well as decreased sales as a result of negative publicity and product liability claims, all of which could have a material adverse effect on our business, results of operation, financial condition or cash flows.
Our second amended and restated bylaws designate the state courts located within the state of Delaware (or if no state court located within Delaware has jurisdiction, the federal district court for the District of Delaware) as the exclusive forum for certain disputes between us and our stockholders, which could limit our stockholders’ ability to access a favorable judicial forum for disputes with us or our directors, officers or employees.
Our third amended and restated bylaws designate the state courts located within the state of Delaware (or if no state court located within Delaware has jurisdiction, the federal district court for the District of Delaware) as the exclusive forum for certain disputes between us and our stockholders, which could limit our stockholders’ ability to access a favorable judicial forum for disputes with us or our directors, officers or employees.
If we or our suppliers fail to adhere to QSR, ISO or other regulatory requirements, this could delay production of our products and lead to fines, difficulties in obtaining regulatory clearances or approvals, recalls or other consequences, which could in turn have a material adverse effect on our business, results of operation, financial condition or cash flows.
If we or our suppliers fail to adhere to QMSR, ISO or other regulatory requirements, this could delay production of our products and lead to fines, difficulties in obtaining regulatory clearances or approvals, recalls or other consequences, which could in turn have a material adverse effect on our business, results of operation, financial condition or cash flows.
By way of example, the European Union regulatory bodies have instituted EU MDR, which changed many aspects of the existing regulatory framework, such as clinical data requirements, and introduced new ones, such as Unique Device Identification. EU MDR imposes increased compliance obligations for many parts of our business in order to access the EU market.
For example, the European Union regulatory bodies have instituted EU MDR, which changed many aspects of the existing regulatory framework, such as clinical data requirements, and introduced new ones, such as Unique Device Identification. EU MDR imposes increased compliance obligations for many parts of our business in order to access the EU market.
In addition, if a court were to find the choice of forum provision contained in our second amended and restated bylaws to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business and financial condition.
In addition, if a court were to find the choice of forum provision contained in our third amended and restated bylaws to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business and financial condition.
Provisions of Delaware law (where we are incorporated), our restated certificate of incorporation and our second amended and restated bylaws may discourage, delay or prevent a merger or acquisition that stockholders may consider favorable, including transactions in which you might otherwise receive a premium for your shares.
Provisions of Delaware law (where we are incorporated), our amended and restated certificate of incorporation and our third amended and restated bylaws may discourage, delay or prevent a merger or acquisition that stockholders may consider favorable, including transactions in which you might otherwise receive a premium for your shares.
If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, demand for our stock could decrease, which might cause our stock price and trading volume to decline. 47 Table of Contents ITEM 1B. UNRESOLVED STAFF COMMENTS. None.
If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, demand for our stock could decrease, which might cause our stock price and trading volume to decline. 48 Table of Contents ITEM 1B. UNRESOLVED STAFF COMMENTS. None.
At this time, we consider it more likely than not that we will have sufficient taxable income in the future that will allow us to realize the benefits of the domestic DTAs we maintain as of December 31, 2024, exclusive of our California tax credit DTAs.
At this time, we consider it more likely than not that we will have sufficient taxable income in the future that will allow us to realize the benefits of the domestic DTAs we maintain as of December 31, 2025, exclusive of our California tax credit DTAs.
In addition, an injury or death that is caused by the activities of our suppliers, such as those that provide us with components and raw materials, or by an aspect of a treatment used in combination with our products, such as a complementary drug or anesthesia, may be the basis for a claim against us by patients, hospitals, healthcare providers or others purchasing or using our products, even if our products were not the actual cause of such injury or death.
In addition, an injury or death that is caused by the activities of our suppliers, such as those that provide us with components and raw materials, or by an aspect of a treatment used in combination with our products, such as a complementary drug or anesthesia, may be the basis for a claim against us by patients, hospitals, healthcare providers 27 Table of Contents or others purchasing or using our products, even if our products were not the actual cause of such injury or death.
We are required to register with FDA as a device manufacturer and as a result, we are subject to periodic inspection by FDA for compliance with FDA’s QSR requirements, which requires manufacturers of medical devices to adhere to certain requirements, including testing, quality control and documentation procedures.
We are required to register with FDA as a device manufacturer and as a result, we are subject to periodic inspection by FDA for compliance with FDA’s QMSR requirements, which requires manufacturers of medical devices to adhere to certain requirements, including testing, quality control and documentation procedures.
In December 2020, we agreed to license the technology for certain of our products to our existing distribution partner in China to permit our partner to manufacture and commercialize such products in China, in exchange for fixed payments upon the transfer of the distinct licensed technology and upon the provision of related regulatory support, as well as, in certain cases, royalty payments on downstream sales of the licensed products, which we expanded to include additional products in February 2022, September 2023 and March 2024.
In December 2020, we agreed to license the technology for certain of our products to our existing distribution partner in China to permit our partner to manufacture and commercialize such products in China, in exchange for fixed payments upon the transfer of the distinct licensed technology and upon the provision of related regulatory support, as well as, in certain cases, royalty payments on downstream sales of the licensed products, which we expanded to 29 Table of Contents include additional products in February 2022, September 2023 and March 2024.
Even if issued, existing or future patents may be challenged, including with respect to ownership, narrowed, invalidated, held unenforceable or circumvented, any of which could limit our ability to prevent competitors and other third parties from developing and marketing similar products or limit the length of terms of patent protection we may have for our products and technologies.
Even 36 Table of Contents if issued, existing or future patents may be challenged, including with respect to ownership, narrowed, invalidated, held unenforceable or circumvented, any of which could limit our ability to prevent competitors and other third parties from developing and marketing similar products or limit the length of terms of patent protection we may have for our products and technologies.
Our restated certificate of incorporation, our second amended and restated bylaws and Delaware law contain provisions that could discourage another company from acquiring us and may prevent attempts by our stockholders to replace or remove our current management.
Our amended and restated certificate of incorporation, our third amended and restated bylaws and Delaware law contain provisions that could discourage another company from acquiring us and may prevent attempts by our stockholders to replace or remove our current management.
FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. 34 Table of Contents Risks Related to Our Intellectual Property We rely on a variety of intellectual property rights, and if we are unable to maintain or protect our intellectual property, our business and results of operations will be harmed.
FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. Risks Related to Our Intellectual Property We rely on a variety of intellectual property rights, and if we are unable to maintain or protect our intellectual property, our business and results of operations will be harmed.
Environmental Protection Agency has proposed regulations aimed at reducing hazardous air pollutants, including emissions of ethylene oxide, and any future regulatory action that requires sterilization facilities to modify their sterilization 24 Table of Contents processes to limit the use of ethylene oxide could impact the supply of sterilization services as well as the cost for such services.
Environmental Protection Agency has proposed regulations aimed at reducing hazardous air pollutants, including emissions of ethylene oxide, and any future regulatory action that requires sterilization facilities to modify their sterilization processes to limit the use of ethylene oxide could impact the supply of sterilization services as well as the cost for such services.
We plan to continue to increase our salesforce. Our experience has been that it takes at least six months, and often longer, before new sales personnel generate enough sales to cover their costs, resulting in increased costs without offsetting revenue during periods in which we are increasing the size of our salesforce.
Our experience has been that it takes at least six months, and often longer, before new sales personnel generate enough sales to cover their costs, resulting in increased costs without offsetting revenue during periods in which we are increasing the size of our salesforce.
Outside of the 35 Table of Contents United States, patents we own or license may become subject to patent opposition or similar proceedings, which may result in loss of scope of some claims or the entire patent. In addition, such proceedings are very complex and expensive, and may divert our management’s attention from our core business.
Outside of the United States, patents we own or license may become subject to patent opposition or similar proceedings, which may result in loss of scope of some claims or the entire patent. In addition, such proceedings are very complex and expensive, and may divert our management’s attention from our core business.
Furthermore, other parties in our supply chain are similarly vulnerable to natural disasters or other sudden, unforeseen, and severe adverse events. A natural disaster or other catastrophic event in any of our major markets could have a material adverse impact on our business, financial condition, results of operations, or cash flows.
Furthermore, other parties in our supply chain are similarly vulnerable to natural disasters or other sudden, unforeseen, and 46 Table of Contents severe adverse events. A natural disaster or other catastrophic event in any of our major markets could have a material adverse impact on our business, financial condition, results of operations, or cash flows.
These broad market and industry factors may harm the market price of our common stock, regardless of our operating performance, and could cause you to lose all or part of 40 Table of Contents your investment in our common stock since you might be unable to sell your shares at or above the price you paid for such shares.
These broad market and industry factors may harm the market price of our common stock, regardless of our operating performance, and could cause you to lose all or part of your investment in our common stock since you might be unable to sell your shares at or above the price you paid for such shares.
Primarily as a result of net operating losses, stock-based compensation, various accruals and reserves, and tax credits, we maintain foreign and domestic DTAs. DTAs reflect an expected benefit to be realized in the future that may be used to reduce the amount of tax that we would otherwise be required to pay in future periods.
Primarily as a result of stock-based compensation, various accruals and reserves, and tax credits, we maintain foreign and domestic DTAs. DTAs reflect an expected benefit to be realized in the future that may be used to reduce the amount of tax that we would otherwise be required to pay in future periods.
Accordingly, although we have multiple contracts with many major GPOs and IDNs, the members of such groups may choose to purchase from our competitors due to the price or quality offered by such competitors, which could result in a decline in our sales and profitability.
Accordingly, although we have multiple contracts with many major GPOs and IDNs, the members of such groups may choose 32 Table of Contents to purchase from our competitors due to the price or quality offered by such competitors, which could result in a decline in our sales and profitability.
The repurchase authorization expires on July 31, 2025. Under this authorization, we entered into an accelerated share repurchase agreement (“ASR”) with JPMorgan Chase Bank, National Association to repurchase $100.0 million of our common stock during the three months ended September 30, 2024.
The repurchase authorization originally expired on July 31, 2025. Under this authorization, we entered into an accelerated share repurchase agreement (“ASR”) with JPMorgan Chase Bank, National Association to repurchase $100.0 million of our common stock during the three months ended September 30, 2024.
Such events could result in the disruption of business processes, network degradation and system downtime, along with the potential that a third party will exploit our critical assets such as intellectual property, proprietary business information and data related to our customers, suppliers and business 45 Table of Contents partners.
Such events could result in the disruption of business processes, network degradation and system downtime, along with the potential that a third party will exploit our critical assets such as intellectual property, proprietary business information and data related to our customers, suppliers and business partners.
FDA and other foreign regulatory authorities worldwide also conduct periodic inspections of our facilities to determine compliance with FDA’s QSR requirements, EU MDR requirements and all comparable foreign regulations.
FDA and other foreign regulatory authorities worldwide also conduct periodic inspections of our facilities to determine compliance with FDA’s QMSR requirements, EU MDR requirements and all comparable foreign regulations.
We may not receive necessary foreign regulatory approvals or clearances or otherwise comply with foreign regulations. For the years ended December 31, 2024, 2023 and 2022, sales outside the United States accounted for approximately 24.5%, 28.5%, and 30.2%, respectively, of our total sales, and we expect sales in non-U.S. markets to continue to represent a significant portion of our revenue.
We may not receive necessary foreign regulatory approvals or clearances or otherwise comply with foreign regulations. For the years ended December 31, 2025, 2024 and 2023, sales outside the United States accounted for approximately 22.2%, 24.5%, and 28.5%, respectively, of our total sales, and we expect sales in non-U.S. markets to continue to represent a significant portion of our revenue.
We are also continuing to improve our internal control over financial reporting. In order to maintain and improve the effectiveness of our disclosure controls and procedures and internal control over financial reporting, we have 46 Table of Contents expended, and anticipate that we will continue to expend, significant resources, including accounting-related costs and significant management oversight.
We are also continuing to improve our internal control over financial reporting. In order to maintain and improve the effectiveness of our disclosure controls and procedures and internal control over financial reporting, we have expended, and anticipate that we will continue to expend, significant resources, including accounting-related costs and significant management oversight.
We may need to expend significant capital resources and further increase the size of our manufacturing capabilities as we grow our business. We could, however, encounter problems related to: • capacity constraints; • production yields; • quality control; • equipment availability; and • shortages of qualified personnel.
We may need to expend significant capital resources and further increase the size of our manufacturing capabilities as we grow our business. We could, however, encounter problems related to: • capacity constraints; • production yields; 26 Table of Contents • quality control; • equipment availability; and • shortages of qualified personnel.
These short attacks have led to selling of shares in the market. We have been in the past, and may be in the future, subject to such attacks by short sellers. If we are the subject of unfavorable allegations, we may have to expend a significant amount of resources to investigate such allegations and/or defend ourselves.
These short attacks have led to selling of shares in the market. We have been in the past, and may be in the future, subject to such attacks by short sellers. If we are the subject of unfavorable allegations, we may have to expend a 43 Table of Contents significant amount of resources to investigate such allegations and/or defend ourselves.
Although we have systems in place to monitor and mitigate risks associated with 44 Table of Contents customer nonpayment, there can be no assurance that such systems will be effective in reducing or eliminating the credit risk relating to the sale of our products.
Although we have systems in place to monitor and mitigate risks associated with customer nonpayment, there can be no assurance that such systems will be effective in reducing or eliminating the credit risk relating to the sale of our products.
In addition, the research, development, marketing and sales of our products are dependent, in part, upon our working relationships with specialist physicians and other healthcare providers. We rely on them to provide us with knowledge and feedback regarding our products and the marketing of our products.
In addition, the research, development, marketing and sales of our products are dependent, in part, upon our working relationships with specialist physicians and other healthcare providers. We rely on them to provide us with knowledge and 25 Table of Contents feedback regarding our products and the marketing of our products.
For 25 Table of Contents example, during the three months ended June 30, 2024, we recorded a $33.4 million write-down of Immersive Healthcare inventory in connection with our strategic decision to explore alternative avenues for our Immersive Healthcare business.
For example, during the three months ended June 30, 2024, we recorded a $33.4 million write-down of immersive healthcare inventory in connection with our strategic decision to explore alternative avenues for our immersive healthcare business.
If current or future distributors or our partner in China do not perform adequately, or if we lose a significant distributor or our partner in China, we may not be able to maintain existing levels of international revenue or realize expected 28 Table of Contents long term international revenue growth.
If current or future distributors or our partner in China do not perform adequately, or if we lose a significant distributor or our partner in China, we may not be able to maintain existing levels of international revenue or realize expected long term international revenue growth.
Investors seeking cash dividends should not invest in our common stock. An additional valuation allowance against our deferred tax assets could require a charge to earnings, which could result in a negative impact on our results of operations.
Investors seeking cash dividends should not invest in our common stock. 44 Table of Contents An additional valuation allowance against our deferred tax assets could require a charge to earnings, which could result in a negative impact on our results of operations.
FDA may require testing 31 Table of Contents and surveillance programs to monitor the effects of cleared or approved products that have been commercialized and can prevent or limit further marketing of a product based on the results of these post-marketing programs.
FDA may require testing and surveillance programs to monitor the effects of cleared or approved products that have been commercialized and can prevent or limit further marketing of a product based on the results of these post-marketing programs.
Any debt financing obtained by us in the future could involve restrictive 39 Table of Contents covenants relating to our capital raising activities and other financial and operational matters, which may make it more difficult for us to obtain additional capital and to pursue business opportunities, including potential acquisitions.
Any debt financing obtained by us in the future could involve restrictive covenants relating to our capital raising activities and other financial and operational matters, which may make it more difficult for us to obtain additional capital and to pursue business opportunities, including potential acquisitions.
As of December 31, 2024, approximately 7,400,000 shares of common stock that are either subject to outstanding options or other equity awards or reserved for future issuance under our equity incentive plans have been registered on Form S-8 registration statements and may be freely sold in the public market upon issuance, except for shares held by affiliates who have certain restrictions on their ability to sell.
As of December 31, 2025, approximately 6,700,000 shares of common stock that are either subject to outstanding options or other equity awards or reserved for future issuance under our equity incentive plans have been registered on Form S-8 registration statements and may be freely sold in the public market upon issuance, except for shares held by affiliates who have certain restrictions on their ability to sell.
Compliance with applicable regulatory requirements is subject to continual review and is rigorously monitored through periodic inspections by FDA. In the European Community, we are required to maintain certain ISO certifications in order to sell products and we undergo periodic inspections by notified bodies to obtain and maintain these certifications.
Compliance with applicable regulatory requirements is subject to continual review and is rigorously monitored through periodic inspections by FDA. In the European Community, we 34 Table of Contents are required to maintain certain ISO certifications in order to sell products and we undergo periodic inspections by notified bodies to obtain and maintain these certifications.
If they succeed in registering or developing common law rights in such trademarks, and if we are not successful in 38 Table of Contents challenging such third-party rights, we may not be able to use these trademarks to market our products in those countries where such third parties have registered such trademarks or obtained such common law rights.
If they succeed in registering or developing common law rights in such trademarks, and if we are not successful in challenging such third-party rights, we may not be able to use these trademarks to market our products in those countries where such third parties have registered such trademarks or obtained such common law rights.
In the event of unauthorized use or disclosure of our trade secrets or proprietary information, these agreements, even if obtained, may not provide meaningful protection, particularly for our trade secrets or other confidential information.
In the event of unauthorized use or disclosure of our trade secrets or proprietary information, these agreements, even 40 Table of Contents if obtained, may not provide meaningful protection, particularly for our trade secrets or other confidential information.
A 23 Table of Contents significant decline in our sales of any of these product families could also negatively impact our financial condition and our ability to conduct product development activities, and therefore negatively impact our business prospects.
A significant decline in our sales of any of these product families could also negatively impact our financial condition and our ability to conduct product development activities, and therefore negatively impact our business prospects.
In addition, we may indemnify our customers and distributors against claims relating to the infringement of intellectual property rights of third parties related to our products. Third parties may assert infringement claims against our customers or 37 Table of Contents distributors.
In addition, we may indemnify our customers and distributors against claims relating to the infringement of intellectual property rights of third parties related to our products. Third parties may assert infringement claims against our customers or distributors.
If key personnel were to leave Penumbra, either to join our competitors or otherwise, we may not be able to attract and retain equally qualified personnel to replace them, which could harm our ability to develop and successfully grow our business.
If key personnel were to leave Penumbra, either to join our competitors or otherwise, we may not be 31 Table of Contents able to attract and retain equally qualified personnel to replace them, which could harm our ability to develop and successfully grow our business.
We received certification to ISO 13485:2016 in 2018 and successfully completed our most recent recertification audit in 2024. Compliance with this standard is subject to continual review and is monitored through periodic inspections by our notified body.
We received certification to ISO 13485:2016 in 2018 and successfully completed our most recent surveillance audit in 2025. Compliance with this standard is subject to continual review and is monitored through periodic inspections by our notified body.
Court of Appeals for the Federal Circuit have made, and will likely continue to make, changes in how the patent laws of the United States are interpreted. Similarly, foreign courts have made, and will likely continue to make, changes in how the patent laws in their respective jurisdictions are interpreted.
Furthermore, the U.S. Supreme Court and the U.S. Court of Appeals for the Federal Circuit have made, and will likely continue to make, changes in how the patent laws of the United States are interpreted. Similarly, foreign courts have made, and will likely continue to make, changes in how the patent laws in their respective jurisdictions are interpreted.
Approximately 24.5%, 28.5%, and 30.2% of our revenue for the years ended December 31, 2024, 2023 and 2022, respectively, were derived from sales in non-U.S. markets, and we expect sales in non-U.S. markets to continue to represent a significant portion of our revenue.
Approximately 22.2%, 24.5%, and 28.5% of our revenue for the years ended December 31, 2025, 30 Table of Contents 2024 and 2023, respectively, were derived from sales in non-U.S. markets, and we expect sales in non-U.S. markets to continue to represent a significant portion of our revenue.
Additional tariffs imposed by the United States on a broader range of imports, or further retaliatory trade measures taken by China or other countries in response, could result in an increase in supply chain costs or other pricing pressures that we may not be able to offset or may otherwise adversely impact our business and results of operations.
Additional tariffs imposed by the United States, or further retaliatory trade measures taken by other countries in response, could result in an increase in supply chain costs or other pricing pressures that we may not be able to offset or may otherwise adversely impact our business and results of operations.
We own 45 trademarks, related to our company name, logo, products and technology, that are registered with the USPTO as well as 225 trademarks registered outside of the United States as of December 31, 2024. Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented, declared generic or determined to be infringing on other marks or names.
We own 46 trademarks, related to our company name, logo, products and technology, that are registered with the USPTO as well as 235 trademarks registered outside of the United States as of December 31, 2025. Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented, declared generic or determined to be infringing on other marks or names.
As of December 31, 2024, our directors, executive officers and holders of 5% or more of our outstanding stock beneficially owned approximately 39.4% of our outstanding stock in the aggregate. If one or more of them were to sell a substantial portion of the shares they hold, it could cause our stock price to decline.
As of December 31, 2025, our directors, executive officers and holders of 5% or more of our outstanding stock beneficially owned approximately 36.2% of our outstanding stock in the aggregate. If one or more of them were to sell a substantial portion of the shares they hold, it could cause our stock price to decline.
We received our first MDSAP certification in 2018 and successfully completed our most recent recertification audit in 2024. Some of our suppliers are subject to the same or similar scrutiny.
We received our first MDSAP certification in 2018 and successfully completed our most recent surveillance audit in 2025. Some of our suppliers are subject to the same or similar scrutiny.
In addition, at certain times we may need to rely on third party consultants, which may cost more than employees and may create operating inefficiencies and 29 Table of Contents difficulties.
In addition, at certain times we may need to rely on third party consultants, which may cost more than employees and may create operating inefficiencies and difficulties.
Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their intellectual property.
Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their intellectual 37 Table of Contents property.
Sales of a substantial number of shares of our common stock could occur at any time. These sales, or the perception in the market that the holders of a large number of shares of common stock intend to sell shares, could reduce the market price of our common stock.
These sales, or the perception in the market that the holders of a large number of shares of common stock intend to sell shares, could reduce the market price of our common stock.
We do not control our distributors, and they may not be successful in implementing our marketing plans. In addition, many of our distributors initially obtain and maintain foreign regulatory approval for the sale of our products in their respective countries, and their efforts in obtaining and maintaining regulatory approval may not be as robust as we desire or expect.
In addition, many of our distributors initially obtain and maintain foreign regulatory approval for the sale of our products in their respective countries, and their efforts in obtaining and maintaining regulatory approval may not be as robust as we desire or expect.
Fluctuations in our effective tax rate and changes to tax laws may adversely affect us. As an international company, we are subject to taxation in numerous countries, states and other jurisdictions. Our effective tax rate is derived from a combination of statutory tax rates in the various jurisdictions in which we operate.
As an international company, we are subject to taxation in numerous countries, states and other jurisdictions. Our effective tax rate is derived from a combination of statutory tax rates in the various jurisdictions in which we operate.
If we are unable to increase the frequency of use of our products by our existing customers and expand our customer base to include additional specialist physicians and other healthcare providers in both our existing and future target end markets, our sales growth will be limited, which could materially adversely affect our business, results of operations, financial condition or cash flows.
If we are unable to increase the frequency of use of our products by our existing customers and expand our customer base to include additional specialist physicians and other healthcare providers in both our existing and future target end markets, our sales growth will be limited, which could materially adversely affect our business, results of operations, financial condition or cash flows. 24 Table of Contents We may not have the resources to successfully market and sell our products, which would adversely affect our business and results of operations.
As of December 31, 2024, our executive officers, directors and holders of 5% or more of our outstanding stock and their affiliates beneficially owned approximately 39.4% of our voting stock in the aggregate.
As of December 31, 2025, our executive officers, directors and holders of 5% or more of our outstanding stock and their affiliates beneficially owned approximately 36.2% of our voting stock in the aggregate.
From January 1, 2024 through December 31, 2024, our closing stock price as reported on The New York Stock Exchange (“NYSE”) has ranged from $ 163.64 to $273.15. Stock markets have experienced extreme volatility that has often been unrelated to the operating performa nce of particular companies.
From January 1, 2025 through December 31, 2025, our closing stock price as reported on The New York Stock Exchange (“NYSE”) has ranged from $ 225.54 to $320.85. Stock markets have experienced extreme volatility that has often been unrelated to the operating performa nce of particular companies.
We have modified and will continue to modify our practices in order to comply with these and other requirements, which requires us to incur costs and expenses, and we may face difficulties in complying with all privacy and data protection legal requirements that apply to us now or in the future, as well as financial penalties and liabilities if we are unable to do so.
We have modified and will continue to modify our practices in order to comply with these and other requirements, which requires us to incur costs and expenses, and we may face difficulties in complying with all privacy and data protection legal requirements that apply to us now or in the future, as well as financial penalties and liabilities if we are unable to do so. 47 Table of Contents We incur significant costs and devote substantial management time as a result of operating as a public company.
We are expanding and renovating our existing facilities around the world but particularly in Alameda, California, driven by our need to expand the space available for our product development and test capacities, as well as our need for additional information technology and office space.
We are expanding and renovating our existing facilities around the world, including in Alameda and Roseville California, and establishing new manufacturing facilities in Costa Rica, driven by our need to expand the space available for product manufacturing and product development and testing capacities, as well as our need for additional information technology and office space.
We rely on our distributors to market and sell our products in certain international markets. We have established a direct sales capability in the United States, most of Europe, Canada and Australia, which we have complemented with distributors in certain other international markets. Sales to distributors represented 13.2%, 16.7% and 18.7% of our revenue in 2024, 2023 and 2022, respectively.
We rely on our distributors to market and sell our products in certain international markets. We have established a direct sales capability in the United States, most of Europe, Canada, Australia and Singapore, which we have complemented with distributors in certain other international markets.
In addition, the United States federal government has imposed and/or threatened tariffs on goods imported from China, Mexico, Canada and certain other countries, which has resulted in retaliatory tariffs imposed and/or threatened by China and other countries.
In addition, the United States federal government has imposed and/or threatened tariffs on a broad range of goods imported from several other countries, which has resulted in retaliatory tariffs imposed and/or threatened by other countries.
During the three months ended September 30, 2024, we repurchased an aggregate of 517,763 shares under the ASR at an aggregate cost of $100.4 million, including legal and financial advisor fees of $0.4 million associated with the repurchase. As of December 31, 2024, we had remaining authority to purchase $100.0 million of its common stock under the share repurchase authorization.
During the three months ended September 30, 2024, we repurchased an aggregate of 517,763 shares under the ASR at an aggregate cost of $100.4 million, including legal and financial advisor fees of $0.4 million associated with the repurchase.
Some of our competitors have: • significantly greater name recognition; • broader or deeper relations with healthcare professionals, customers, group purchasing organizations and third-party payors; • more established distribution networks; • additional lines of products and the ability to offer rebates or bundle products to offer greater discounts or other incentives to gain a competitive advantage; • greater experience in conducting research and development, manufacturing, clinical trials, marketing and obtaining regulatory clearance or approval for products; and • greater financial and human resources for product development, sales and marketing and patent litigation.
Some of our competitors have: • significantly greater name recognition; • broader or deeper relations with healthcare professionals, customers, group purchasing organizations and third-party payors; • more established distribution networks; • additional lines of products and the ability to offer rebates or bundle products to offer greater discounts or other incentives to gain a competitive advantage; • greater experience in conducting research and development, manufacturing, clinical trials, marketing and obtaining regulatory clearance or approval for products; and • greater financial and human resources for product development, sales and marketing and patent litigation. 23 Table of Contents We compete primarily on the basis that our products are able to treat patients with neuro and vascular diseases and disorders and other health conditions safely and effectively, with improved outcomes and procedural cost savings.
Unfavorable or inconsistent clinical data from existing or future clinical trials conducted by us, our competitors or third parties, or the market’s or regulators’ perception of clinical data, may reduce adoption of our products, which could materially adversely affect our business, results of operations, financial condition or cash flows. 26 Table of Contents Negative publicity regarding our products or marketing tactics by competitors or other third parties could reduce demand for our products, which would adversely affect sales and our financial performance.
Unfavorable or inconsistent clinical data from existing or future clinical trials conducted by us, our competitors or third parties, or the market’s or regulators’ perception of clinical data, may reduce adoption of our products, which could materially adversely affect our business, results of operations, financial condition or cash flows.
The Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business, results of operation, financial condition or cash flows.
The Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business, results of operation, financial condition or cash flows. 39 Table of Contents In addition, patent reform legislation may pass in the future that could lead to additional uncertainties and increased costs surrounding the prosecution, enforcement and defense of our patents and applications.
This concentration of ownership may have the effect of delaying, preventing or deterring a change in control of our company, could deprive our stockholders of an opportunity to receive a premium for their common stock as part of a sale of our company and might ultimately affect the market price of our common stock. 41 Table of Contents A sale of a substantial number of shares of our common stock in the public market could cause the market price of our common stock to drop significantly, even if our business is doing well.
This concentration of ownership may have the effect of delaying, preventing or deterring a change in control of our company, could deprive our stockholders of an opportunity to receive a premium for their common stock as part of a sale of our company and might ultimately affect the market price of our common stock.
These provisions include: • authorizing the issuance of “blank check” preferred stock without any need for action by stockholders; • requiring supermajority stockholder voting to effect certain amendments to our restated certificate of incorporation and second amended and restated bylaws; • eliminating the ability of stockholders to call and bring business before special meetings of stockholders; • prohibiting stockholder action by written consent; • establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on by stockholders at stockholder meetings; • dividing our board of directors into three classes so that only one third of our directors will be up for election in any given year; and • providing that our directors may be removed by our stockholders only for cause.
These provisions include: • authorizing the issuance of “blank check” preferred stock without any need for action by stockholders; • eliminating the ability of stockholders to call and bring business before special meetings of stockholders; • prohibiting stockholder action by written consent; • establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on by stockholders at stockholder meetings; and • providing that our directors may be removed by our stockholders only for cause.
Our competition may respond more quickly to new or emerging technologies or a changing clinical landscape, undertake more extensive marketing campaigns, have greater financial, marketing and other resources than us or be more successful in attracting potential customers and strategic partners. The success of any new products that we develop or acquire depends on achieving and maintaining market acceptance.
Our competition may respond more quickly to new or emerging technologies or a 22 Table of Contents changing clinical landscape, undertake more extensive marketing campaigns, have greater financial, marketing and other resources than us or be more successful in attracting potential customers and strategic partners.
We may not have the resources to successfully market and sell our products, which would adversely affect our business and results of operations. The marketing and sales of our products requires us to invest in training and education and employ a salesforce that is large enough to interact with the specialist physicians and other healthcare providers who use our products.
The marketing and sales of our products requires us to invest in training and education and employ a salesforce that is large enough to interact with the specialist physicians and other healthcare providers who use our products.

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Item 2. Properties

Properties — owned and leased real estate

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Biggest changeAn additional approximately 50,000 square feet of space in one of the buildings, located at 620 Roseville Parkway, will be added to the lease upon the completion of certain improvements to the premises, which are expected to commence in 2025.
Biggest changeThe lease will commence upon the completion of certain improvements to the premises, which are expected to be completed in 2026, and will expire five years after commencement, subject to our option to renew the lease for an additional three years.
ITEM 2. PROPERTIES. We maintain approximately 610,000 square feet of office, research and development, manufacturing and administrative facilities in nine buildings at our campus in Alameda, California as of December 31, 2024. The leases for these nine buildings expire at various times in 2036, subject to our option to renew certain leases for an additional five to fifteen years.
ITEM 2. PROPERTIES. We maintain approximately 610,000 square feet of office, research and development, manufacturing and administrative facilities in nine buildings at our campus in Alameda, California as of December 31, 2025. The leases for these nine buildings expire at various times in 2036, subject to our option to renew certain leases for an additional five to fifteen years.
We also lease approximately 210,000 square feet of office and manufacturing facilities in two buildings in Roseville, California. The leases for these two buildings expire in 2035, subject to our option to renew the leases for an additional five to ten years.
We also lease approximately 260,000 square feet of office and manufacturing facilities in two buildings in Roseville, California. The leases for these two buildings expire in 2035, subject to our option to renew the leases for an additional five to ten years.
The lease for the Salt Lake City warehouse expires in 2027, subject to our option to renew the lease for an additional five years. 48 Table of Contents We also lease office and/or warehouse space in Germany, Italy, Brazil, Australia, Singapore, Japan, Hong Kong and Taiwan as of December 31, 2024.
The lease for the Salt Lake City warehouse expires in 2027, subject to our option to renew the lease for an additional five years. We also lease office and/or warehouse space in Germany, Italy, Poland, Brazil, Australia, Singapore, Japan, Hong Kong and Taiwan as of December 31, 2025.
The office in Germany supports our direct sales operations in Europe as well as distributor relationships in Europe and the Middle East; the offices in Brazil, Australia, Singapore, Japan, Hong Kong and Taiwan support our sales and marketing efforts, including through our distribution partners, in Latin America, Australia and Southeast Asia, respectively; and the offices in Italy support the operations of Crossmed S.p.A., our wholly-owned subsidiary in Italy, including supporting our direct sales operations in Italy, San Marino, Vatican City, and Switzerland.
The offices in Germany and Poland support our direct sales and/or customer service 49 Table of Contents operations in Europe as well as distributor relationships in Europe, the Middle East and Africa; the offices in Brazil, Australia, Singapore, Japan, Hong Kong and Taiwan support our sales and marketing efforts, including through our distribution partners, in Latin America, Australia and Southeast Asia, respectively; and the offices in Italy support the operations of Crossmed S.p.A., our wholly-owned subsidiary in Italy, including supporting our direct sales operations in Italy, San Marino, Vatican City, and Switzerland.
In addition, we lease approximately 70,000 square feet of warehouse space in Livermore, California, and approximately 100,000 square feet of warehouse space in Salt Lake City, Utah. The leases for the Livermore warehouse spaces expire at various times in 2025 to 2028.
In addition, we lease approximately 51,000 square feet of warehouse space in Livermore, California, and approximately 100,000 square feet of warehouse space in Salt Lake City, Utah. The leases for the Livermore warehouse spaces expire in 2028.
We also warehouse and distribute finished products to our international customers utilizing third-party logistics providers in the Netherlands and Australia.
We also warehouse and distribute finished products to our international customers utilizing third-party logistics providers in the Netherlands and Australia. During the year ended December 31, 2025, we entered into agreements to acquire property in Costa Rica and construct a manufacturing facility and warehouse for the production of medical devices. Refer to Note “5.
Added
Balance Sheet Components” to our consolidated financial statements in Part II, Item 8 of this Form 10-K for more information. In addition, during the year ended December 31, 2025, we entered into an agreement to lease approximately 46,000 square feet of manufacturing and warehouse facilities in Costa Rica.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeThis graph shall not be deemed “soliciting material” or be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities under that Section, and shall not be deemed to be incorporated by reference into any of our filings under the Securities Act or the Exchange Act, whether made before or after the date hereof and irrespective of any general incorporation language in any such filing. $100 investment in stock or index Ticker 12/31/2019 12/31/2020 12/31/2021 12/30/2022 12/29/2023 12/31/2024 Penumbra PEN $ 100.00 $ 106.53 $ 174.91 $ 135.42 $ 153.13 $ 144.57 NYSE Composite NYA 100.00 104.40 123.37 109.14 121.13 137.26 S&P 500 Healthcare Equipment Index XHE 100.00 132.91 136.96 104.99 98.45 103.45 Dividend Policy We have never declared or paid cash dividends on our capital stock and do not anticipate paying any cash dividends in the foreseeable future.
Biggest changeThis graph shall not be deemed “soliciting material” or be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities under that Section, and shall not be deemed to be incorporated by reference into any of our filings under the Securities Act or the Exchange Act, whether made before or after the date hereof and irrespective of any general incorporation language in any such filing. $100 investment in stock or index Ticker 12/31/2020 12/31/2021 12/30/2022 12/29/2023 12/31/2024 12/31/2025 Penumbra PEN $ 100.00 $ 164.18 $ 127.12 $ 143.74 $ 135.70 $ 177.66 NYSE Composite NYA 100.00 118.17 104.54 116.03 131.48 151.49 S&P Healthcare Equipment Index XHE 100.00 103.04 78.99 74.07 77.83 77.66 Dividend Policy We have never declared or paid cash dividends on our capital stock and do not anticipate paying any cash dividends in the foreseeable future.
Any future determination related to dividend policy will be made at the discretion of our board of directors, subject to applicable laws, and will depend on a number of factors, including our financial condition, results of operations, capital requirements, contractual restrictions, general business conditions and other factors that our board of directors may deem relevant. 51 Table of Contents Issuer Purchases of Equity Securities None.
Any future determination related to dividend policy will be made at the discretion of our board of directors, subject to applicable laws, and will depend on a number of factors, including our financial condition, results of operations, capital requirements, contractual restrictions, general business conditions and other factors that our board of directors may deem relevant. 52 Table of Contents Issuer Purchases of Equity Securities None.
The figures represented below assume an investment of $100 in our common stock on December 31, 2019 and in the S&P Healthcare Equipment Index and NYSE Composite and the reinvestment of dividends into shares of common stock for the years ended December 31, 2020, 2021, 2022, 2023 and 2024.
The figures represented below assume an investment of $100 in our common stock on December 31, 2020 and in the S&P Healthcare Equipment Index and NYSE Composite and the reinvestment of dividends into shares of common stock for the years ended December 31, 2021, 2022, 2023, 2024 and 2025.
As of February 4, 2025, there were 22 holders of record of our common stock. The actual number of stockholders is greater than this number of record holders, and includes stockholders who are beneficial owners, but whose shares are held in street name by brokers and other nominees.
As of February 4, 2026, there were 19 holders of record of our common stock. The actual number of stockholders is greater than this number of record holders, and includes stockholders who are beneficial owners, but whose shares are held in street name by brokers and other nominees.
Performance Graph The following graph illustrates a comparison of the total cumulative stockholder return on our common stock with the total return for (i) the S&P Healthcare Equipment Index and (ii) the NYSE Composite for the period from December 31, 2019 through December 31, 2024.
Performance Graph The following graph illustrates a comparison of the total cumulative stockholder return on our common stock with the total return for (i) the S&P Healthcare Equipment Index and (ii) the NYSE Composite for the period from December 31, 2020 through December 31, 2025.
Recent Sales of Unregistered Securities None. 52 Table of Contents
Recent Sales of Unregistered Securities None. 53 Table of Contents

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeResults of Operations The following table sets forth the components of our consolidated statements of operations in U.S. dollars and as a percentage of revenue for the periods presented: Year Ended December 31, 2024 2023 2022 (in thousands, except for percentages) Revenue $ 1,194,615 100.0 % $ 1,058,522 100.0 % $ 847,133 100.0 % Cost of revenue 439,620 36.8 % 375,879 35.5 % 311,926 36.8 % Gross profit 754,995 63.2 % 682,643 64.5 % 535,207 63.2 % Operating expenses: Research and development 94,783 7.9 % 84,423 8.0 % 79,407 9.4 % Sales, general and administrative 573,988 48.0 % 506,454 47.8 % 449,718 53.1 % Acquired in-process research and development — — % 18,215 1.7 % — — % Impairment charge 76,945 6.5 % — — % — — % Total operating expenses 745,716 62.4 % 609,092 57.5 % 529,125 62.5 % Income from operations 9,279 0.8 % 73,551 6.9 % 6,082 0.7 % Interest and other income (expense), net 11,590 0.9 % 6,099 0.6 % (2,190) (0.3) % Income before income taxes 20,869 1.7 % 79,650 7.5 % 3,892 0.5 % Provision for (benefit from) income taxes 6,857 0.5 % (11,304) (1.1) % 5,894 0.7 % Net income (loss) $ 14,012 1.2 % $ 90,954 8.6 % $ (2,002) (0.2) % 59 Table of Contents Year Ended December 31, 2024 Compared to Year Ended December 31, 2023 Revenue Year Ended December 31, Change 2024 2023 $ % (in thousands, except for percentages) Thrombectomy $ 815,475 $ 677,343 $ 138,132 20.4 % Embolization and Access 379,140 381,179 (2,039) (0.5) % Total $ 1,194,615 $ 1,058,522 $ 136,093 12.9 % Revenue increased $136.1 million, or 12.9%, to $1,194.6 million in 2024, from $1,058.5 million in 2023.
Biggest changeA valuation allowance is established when it is more likely than not that the future realization of all or some of the DTAs will not be achieved. 59 Table of Contents Results of Operations The following table sets forth the components of our consolidated statements of operations in U.S. dollars and as a percentage of revenue for the periods presented: Year Ended December 31, 2025 2024 2023 (in thousands, except for percentages) Revenue $ 1,403,665 100.0 % $ 1,194,615 100.0 % $ 1,058,522 100.0 % Cost of revenue 461,228 32.9 % 439,620 36.8 % 375,879 35.5 % Gross profit 942,437 67.1 % 754,995 63.2 % 682,643 64.5 % Operating expenses: Research and development 89,766 6.4 % 94,783 7.9 % 84,423 8.0 % Sales, general and administrative 663,422 47.3 % 573,988 48.0 % 506,454 47.8 % Acquired in-process research and development — — % — — % 18,215 1.7 % Impairment charge — — % 76,945 6.5 % — — % Total operating expenses 753,188 53.7 % 745,716 62.4 % 609,092 57.5 % Income from operations 189,249 13.5 % 9,279 0.8 % 73,551 6.9 % Interest and other income 15,876 1.1 % 11,590 0.9 % 6,099 0.6 % Income before income taxes 205,125 14.6 % 20,869 1.7 % 79,650 7.5 % Provision for (benefit from) income taxes 27,438 1.9 % 6,857 0.5 % (11,304) (1.1) % Net income $ 177,687 12.7 % $ 14,012 1.2 % $ 90,954 8.6 % 60 Table of Contents Year Ended December 31, 2025 Compared to Year Ended December 31, 2024 Revenue Year Ended December 31, Change 2025 2024 $ % (in thousands, except for percentages) Thrombectomy $ 947,918 $ 815,475 $ 132,443 16.2 % Embolization and Access 455,747 379,140 76,607 20.2 % Total $ 1,403,665 $ 1,194,615 $ 209,050 17.5 % Revenue increased $209.1 million, or 17.5%, to $1,403.7 million in 2025, from $1,194.6 million in 2024.
Net Cash (Used In) Provided By Financing Activities Net cash (used in) provided by financing activities primarily relates to repurchases of our common stock, payments towards the reduction of our finance lease obligations and payments of employee taxes related to vested restricted stock units, partially offset by proceeds from issuances of common stock under our employee stock purchase plan and exercises of stock options.
Net Cash Provided By (Used In) Financing Activities Net cash provided by (used in) financing activities primarily relates to proceeds from issuances of common stock under our employee stock purchase plan and exercises of stock options, partially offset by payments of employee taxes related to vested restricted stock units, payments towards the reduction of our finance lease obligations, and repurchases of our common stock.
In the fourth quarter of 2024 and 2023, we performed qualitative assessments for goodwill impairment and determined there were no indicators of impairment. Refer to Note “8. Goodwill” to our consolidated financial statements in Part II, Item 8 of this Form 10-K for more information.
In the fourth quarter of 2025, 2024 and 2023, we performed qualitative assessments for goodwill impairment and determined there were no indicators of impairment. Refer to Note “8. Goodwill” to our consolidated financial statements in Part II, Item 8 of this Form 10-K for more information.
Net Cash Provided By (Used In) Investing Activities Net cash provided by (used in) investing activities relates primarily to proceeds from maturities of marketable investments, partially offset by purchases of marketable and non-marketable investments, capital expenditures, and payments in connection with asset acquisitions.
Net Cash (Used In) Provided By Investing Activities Net cash (used in) provided by investing activities primarily relates to purchases of marketable and non-marketable investments, capital expenditures, payments in connection with asset acquisitions, partially offset by sales of marketable investments and proceeds from maturities of marketable investments.
Variable consideration is included in revenue only to the extent that it is probable that a significant reversal of the revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. During the year ended December 31, 2024, we made no material changes in estimates for variable consideration.
Variable consideration is included in revenue only to the extent that it is probable that a significant reversal of the revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. During the year ended December 31, 2025, we made no material changes in estimates for variable consideration.
In December 2021, the Organizational for Economic Co-operation and Development (“OECD”) released guidance on the new global minimum tax regime known as Pillar Two. Subsequently, safe harbor provisions were introduced to temporarily alleviate administrative compliance burden of multinational enterprises.
In December 2021, the Organization for Economic Co-operation and Development (“OECD”) released guidance on the new global minimum tax regime known as Pillar Two. Subsequently, safe harbor provisions were introduced to temporarily alleviate administrative compliance burden of multinational enterprises.
The Company incurred a $33.4 million charge to cost of revenue for the write-down of Immersive Healthcare inventory to net realizable value, an impairment charge to long-lived assets consisting of $58.9 million in finite-lived intangible assets and $18.0 million in property and equipment, and severance and other associated costs of $5.0 million included in research and development and sales, general and administrative within the consolidated statement of operations.
The Company incurred a $33.4 million charge to cost of revenue for the write-down of immersive healthcare inventory to net realizable value, an impairment charge to long-lived assets consisting of $58.9 million in finite-lived intangible 62 Table of Contents assets and $18.0 million in property and equipment, and severance and other associated costs of $5.0 million included in research and development and sales, general and administrative within the consolidated statement of operations.
Refer to Note “19. Revenues” to our consolidated financial statements in Part II, Item 8 of this Form 10-K for more information and disclosures on our revenue. 55 Table of Contents Certain arrangements with customers contain multiple performance obligations. For these contracts, each promise is evaluated to determine if it is a performance obligation.
Refer to Note “19. Revenues” to our consolidated financial statements in Part II, Item 8 of this Form 10-K for more information and disclosures on our revenue. Certain arrangements with customers contain multiple performance obligations. For these contracts, each promise is evaluated to determine if it is a performance obligation.
The change in operating assets and liabilities includes an increase in inventories of $65.7 million to support our revenue growth, a decrease in accounts receivable of $26.6 million due to timing of invoicing and collections, an increase in accrued expenses and other non-current liabilities of $14.1 million primarily as a result of the growth in our business activities, and an increase in accounts 63 Table of Contents payable of $4.2 million.
The change in operating assets and liabilities includes an increase in inventories of $65.7 million to support our revenue growth, a decrease in accounts receivable of $26.6 million due to timing of invoicing and collections, an increase in accrued expenses and other non-current liabilities of $14.1 million primarily as a result of the growth in our business activities, and an increase in accounts payable of $4.2 million.
These factors include: • The rate at which we grow our salesforce and the speed at which newly hired salespeople become fully effective can impact our revenue growth or our costs incurred in anticipation of such growth. 54 Table of Contents • Our industry is intensely competitive and, in particular, we compete with a number of large, well-capitalized companies.
These factors include: • The rate at which we grow our salesforce and the speed at which newly hired salespeople become fully effective can impact our revenue growth or our costs incurred in anticipation of such growth. • Our industry is intensely competitive and, in particular, we compete with a number of large, well-capitalized companies.
The repurchase authorization expires on July 31, 2025. Under this authorization, the Company entered into an accelerated share repurchase agreement (“ASR”) with JPMorgan Chase Bank, National Association to repurchase $100.0 million of the Company’s common stock during the three months ended September 30, 2024.
The repurchase authorization originally expired on July 31, 2025. Under this authorization, the Company entered into an accelerated share repurchase agreement (“ASR”) with JPMorgan Chase Bank, National Association to repurchase $100.0 million of the Company’s common stock during the three months ended September 30, 2024.
This was partially offset by an increase in prepaid expenses and other current and non-current assets of $2.9 million. Net cash provided by operating activities was $97.3 million in 2023 and consisted of net income of $91.0 million and net changes in operating assets and liabilities of $79.1 million offset by non-cash items of $85.5 million.
This was partially offset by an increase in prepaid expenses and other current and non-current assets of $2.9 million. 64 Table of Contents Net cash provided by operating activities was $97.3 million in 2023 and consisted of net income of $91.0 million and net changes in operating assets and liabilities of $79.1 million offset by non-cash items of $85.5 million.
A discussion of our results of operations for the year ended December 31, 2023 as compared to the year ended December 31, 2022 is included in Part II, Item 7.
A discussion of our results of operations for the year ended December 31, 2024 as compared to the year ended December 31, 2023 is included in Part II, Item 7.
We follow FASB ASC 740-10 “Accounting for Uncertainty in Income Taxes” that prescribes a financial statement recognition threshold and measurement attribute for uncertain tax positions taken or expected to be taken on our income tax returns, and also provides guidance on derecognition, classification, interest and penalty accrual, accounting in interim periods, and disclosure requirements.
We follow FASB ASC 740-10 “Accounting for Uncertainty in Income Taxes” that prescribes a financial statement recognition threshold and measurement attribute for uncertain tax positions taken or expected to be taken on our income tax returns, and also provides guidance on derecognition, classification, interest and penalty accrual, accounting in interim periods, 57 Table of Contents and disclosure requirements.
During the three months ended September 30, 2024, the Company repurchased an aggregate of 517,763 shares under the ASR at an aggregate cost of $100.4 million, including legal and financial advisor fees of $0.4 million associated with the repurchase.
During the 63 Table of Contents three months ended September 30, 2024, the Company repurchased an aggregate of 517,763 shares under the ASR at an aggregate cost of $100.4 million, including legal and financial advisor fees of $0.4 million associated with the repurchase.
"Management's Discussion and Analysis of Financial Condition and Results of Operations" of our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on February 22, 2024, and is incorporated by reference into this Form 10-K.
"Management's Discussion and Analysis of Financial Condition and Results of Operations" of our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on February 18, 2025, and is incorporated by reference into this Form 10-K.
We expect to continue to make investments as we launch new products, expand our manufacturing operations and information technology infrastructures and 62 Table of Contents further expand into international markets. We may, however, require or elect to secure additional financing as we continue to execute our business strategy.
We expect to continue to make investments as we launch new products, expand our manufacturing operations and information technology infrastructures and further expand into international markets. We may, however, require or elect to secure additional financing as we continue to execute our business strategy.
This was partially offset by $8.0 million of payments of employee taxes related to vested restricted stock units and payments related to finance lease obligations of $1.8 million. 64 Table of Contents Contractual Obligations and Commitments In the normal course of business, the Company enters into contracts and commitments that obligate us to make payments in the future.
This was partially offset by $2.1 million of payments of employee taxes related to vested restricted stock units and payments related to finance lease obligations of $2.0 million. Contractual Obligations and Commitments In the normal course of business, the Company enters into contracts and commitments that obligate us to make payments in the future.
We sell our products to healthcare providers primarily through our direct sales organization in the United States, most of Europe, Canada and Australia, as well as through distributors in select international markets. We generated revenue of $1,194.6 million, $1,058.5 million and $847.1 million for the years ended December 31, 2024, 2023 and 2022, respectively.
We sell our products to healthcare providers primarily through our direct sales organization in the United States, most of Europe, Canada, Australia and Singapore, as well as through distributors in select international markets. We generated revenue of $1,403.7 million, $1,194.6 million and $1,058.5 million for the years ended December 31, 2025, 2024 and 2023, respectively.
R&D expenses also include salaries, benefits and other related costs, including stock-based compensation, for personnel and consultants. We expense R&D costs as they are incurred. 58 Table of Contents Sales, General and Administrative (“SG&A”) .
R&D expenses also include salaries, benefits and other related costs, including stock-based compensation, for personnel and consultants. We expense R&D costs as they are incurred. Sales, General and Administrative (“SG&A”) .
This increase in our global thrombectomy products was primarily attributable to higher sales volume in the United States as a result of sales of new products and further market penetration of our existing products. Sales of our U.S. thrombectomy products increased by 26.8% in the year ended December 31, 2024.
This increase in our global thrombectomy products was primarily attributable to higher sales volume in the United States as a result of sales of new products and further market penetration of our existing products. Sales of our U.S. thrombectomy products increased by 19.3% in the year ended December 31, 2025.
Our broad portfolio, which includes computer assisted vacuum thrombectomy (CAVT), centers on removing blood clots from head-to-toe with speed, safety, and simplicity. Our team focuses on developing, manufacturing and marketing novel products for use by specialist physicians and healthcare providers to drive improved clinical and health outcomes. We believe that the cost-effectiveness of our products is attractive to our customers.
Our broad portfolio, which includes computer assisted vacuum thrombectomy (CAVT), centers on removing blood clots from head-to-toe with speed, safety, and simplicity. Our team focuses on developing, manufacturing and marketing novel products for use by specialist physicians and other healthcare providers to drive improved clinical and health outcomes.
We review the status of each significant matter quarterly and assess our potential financial exposure. Significant judgment is required in the determination of whether a potential loss is probable, reasonably possible, or remote as well as in the determination of whether a potential exposure is reasonably estimable. We base our judgments on the best information available at the time.
Significant judgment is required in the determination of whether a potential loss is probable, reasonably possible, or remote as well as in the determination of whether a potential exposure is reasonably estimable. We base our judgments on the best information available at the time.
The following table sets forth, for the periods indicated, our beginning balance of cash and cash equivalents, net cash flows provided by (used in) operating, investing and financing activities and our ending balance of cash and cash equivalents: Year Ended December 31, 2024 2023 2022 (in thousands) Cash and cash equivalents at beginning of year $ 167,486 $ 69,858 $ 59,379 Net cash provided by (used in) operating activities 168,481 97,333 (55,661) Net cash provided by (used in) investing activities 77,624 (16,076) 54,790 Net cash (used in) provided by financing activities (87,006) 16,203 11,622 Cash and cash equivalents at end of year 324,404 167,486 69,858 Net Cash Provided By (Used In) Operating Activities Net cash provided by (used in) operating activities consists primarily of net income adjusted for certain non-cash items (including depreciation and amortization, stock-based compensation expense, acquired in-process research and development, impairment charges, inventory write-offs and write-downs, changes in deferred tax balances, and the effect of changes in working capital and other activities).
The following table sets forth, for the periods indicated, our beginning balance of cash and cash equivalents, net cash flows provided by (used in) operating, investing and financing activities and our ending balance of cash and cash equivalents: Year Ended December 31, 2025 2024 2023 (in thousands) Cash and cash equivalents at beginning of year $ 324,404 $ 167,486 $ 69,858 Net cash provided by operating activities 238,663 168,481 97,333 Net cash (used in) provided by investing activities (404,590) 77,624 (16,076) Net cash provided by (used in) financing activities 26,532 (87,006) 16,203 Effect of foreign exchange rate changes on cash and cash equivalents 1,888 (2,181) 168 Cash and cash equivalents at end of year 186,897 324,404 167,486 Net Cash Provided By Operating Activities Net cash provided by operating activities consists primarily of net income adjusted for certain non-cash items (including depreciation and amortization, stock-based compensation expense, impairment charges, inventory write-offs and write-downs, changes in deferred tax balances, acquired in-process research and development, and the effect of changes in working capital and other activities).
We have continued to make investments, and plan to continue to make investments, in the development of our products. As part of our ongoing investment in the development of our products, we may incur additional expenses related to research and development milestones.
As part of our ongoing investment in the development of our products, we may incur additional expenses related to research and development milestones.
This represents an annual increase of 12.9% and of 25.0%, respectively. We generated income from operations of $9.3 million, $73.6 million and $6.1 million for the years ended December 31, 2024, 2023 and 2022, respectively.
This represents an annual increase of 17.5% and of 12.9%, respectively. We generated income from operations of $189.2 million, $9.3 million and $73.6 million for the years ended December 31, 2025, 2024 and 2023, respectively.
As of December 31, 2024, we had federal research and development tax credits of $2.0 million which are carried forward for 20 years and will expire in 2044. We had California state research and development tax credits of $32.6 million that may be carried forward indefinitely.
As of December 31, 2025, we had federal research and development tax credits of $3.3 million which are carried forward for 20 years and will expire beginning in 2044. We had California state research and development tax credits of $35.4 million that may be carried forward indefinitely.
Cost of revenue consists primarily of the cost of raw materials and components, personnel costs, including stock-based compensation, inbound freight charges, receiving costs, inspection and testing costs, warehousing costs, royalty expense, shipping and handling costs and other labor and overhead costs incurred in the manufacturing of products.
Cost of revenue consists primarily of the cost of raw materials and components, personnel costs, including stock-based compensation, inbound freight charges, receiving costs, inspection and testing costs, warehousing costs, royalty expense, handling costs, which are costs incurred to handle products by a third-party shipper to the customers, and other labor and overhead costs incurred in the manufacturing of products.
Gross margin is impacted by product mix, regional mix, 60 Table of Contents and production initiatives to support demand and create future efficiencies. As such, with favorable product mix, improvement in productivity, and by leveraging our fixed costs on higher volume of new product sales during the year, our gross margin may be positively impacted in the future.
As such, with favorable product mix, improvement 61 Table of Contents in productivity, and by leveraging our fixed costs on higher volume of new product sales during the year, our gross margin may be positively impacted in the future.
Revenue from international sales represented 24.5% and 28.5% of our total revenue in 2024 and 2023, respectively.
Revenue from international sales represented 22.2% and 24.5% of our total revenue in 2025 and 2024, respectively.
Since our founding in 2004, we have invested heavily in our product development and commercial expansion that has established the foundation of our global organization.
We believe that the cost-effectiveness of our products is attractive to our customers. Since our founding in 2004, we have invested heavily in our product development and commercial expansion that has established the foundation of our global organization.
Research and Development (“R&D”) Year Ended December 31, Change 2024 2023 $ % (in thousands, except for percentages) R&D $ 94,783 $ 84,423 $ 10,360 12.3 % R&D as a percentage of revenue 7.9 % 8.0 % R&D expenses increased by $10.4 million or 12.3%, to $94.8 million in 2024, from $84.4 million in 2023.
Research and Development (“R&D”) Year Ended December 31, Change 2025 2024 $ % (in thousands, except for percentages) R&D $ 89,766 $ 94,783 $ (5,017) (5.3) % R&D as a percentage of revenue 6.4 % 7.9 % R&D expenses decreased by $5.0 million or 5.3%, to $89.8 million in 2025, from $94.8 million in 2024.
We still had approximately $44.6 million of state net operating loss (“NOL”) carryforwards available to offset future taxable income as of December 31, 2024. The state NOL carryforwards have different carryover periods and will begin to expire as early as 2036.
The Company had $43.9 million of state net operating loss (“NOL”) carryforwards available to offset future taxable income as of December 31, 2025. The state NOL carryforwards have different carryover periods and will begin to expire as early as 2037.
Prices for our thrombectomy products remained substantially unchanged during the period. Revenue from our global embolization and access products decreased $2.0 million, or 0.5%, to $379.1 million in the year ended December 31, 2024, from $381.2 million in the year ended December 31, 2023.
Prices for our thrombectomy products remained substantially unchanged during the period. Revenue from our global embolization and access products increased $76.6 million, or 20.2%, to $455.7 million in the year ended December 31, 2025, from $379.1 million in the year ended December 31, 2024.
For more information on these royalty obligations, refer to Note “10. Commitments and Contingencies” to our consolidated financial statements in Part II, Item 8 of this Form 10-K. Recently Issued Accounting Standards For information with respect to recently issued accounting standards and the impact of these standards on our consolidated financial statements, refer to Note “2.
Commitments and Contingencies”, and Note “15. Income Taxes”, respectively. Recently Issued Accounting Standards For information with respect to recently issued accounting standards and the impact of these standards on our consolidated financial statements, refer to Note “2. Summary of Significant Accounting Policies” to our consolidated financial statements in Part II, Item 8 of this Form 10-K. 65 Table of Contents
We recognize revenue when control of the promised goods or services is transferred to our customers, in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services.
Revenue Recognition Revenue is primarily comprised of product revenue net of returns, discounts, administration fees and sales rebates. We recognize revenue when control of the promised goods or services is transferred to our customers, in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services.
We include interest and penalties related to unrecognized tax benefits within income tax expense in the accompanying consolidated statements of operations. As of December 31, 2024, our net DTA balance on a consolidated basis was $99.7 million, after reduction of a valuation allowance of $26.6 million. In 2024, we used up all federal net operating loss (“NOL”) carryforwards.
We include interest and penalties related to unrecognized tax benefits within income tax expense in the accompanying consolidated statements of operations. As of December 31, 2025, our net DTA balance on a consolidated basis was $78.7 million, after reduction of a valuation allowance of $28.8 million.
Sales, General and Administrative (“SG&A”) Year Ended December 31, Change 2024 2023 $ % (in thousands, except for percentages) SG&A $ 573,988 $ 506,454 $ 67,534 13.3 % SG&A as a percentage of revenue 48.0 % 47.8 % SG&A expenses increased by $67.5 million, or 13.3%, to $574.0 million in 2024, from $506.5 million in 2023.
Sales, General and Administrative (“SG&A”) Year Ended December 31, Change 2025 2024 $ % (in thousands, except for percentages) SG&A $ 663,422 $ 573,988 $ 89,434 15.6 % SG&A as a percentage of revenue 47.3 % 48.0 % SG&A expenses increased by $89.4 million, or 15.6%, to $663.4 million in 2025, from $574.0 million in 2024.
The change in operating assets and liabilities includes an increase in inventories of $74.6 million to support our revenue growth, an increase in accounts receivable of $69.9 million, and an increase in prepaid expenses and other current and non-current assets of $1.2 million.
The change in operating assets and liabilities includes an increase in inventories of $26.5 million to support our growth, an increase in accounts receivable of $19.5 million, and an increase in prepaid expenses and other current and non-current assets of $12.7 million.
Overall revenue growth was primarily due to an increase in sales of our new and existing thrombectomy products. Revenue from our global thrombectomy products increased $138.1 million, or 20.4%, to $815.5 million in 2024, from $677.3 million in 2023.
Overall revenue growth was primarily due to an increase in sales of our new and existing thrombectomy and embolization and access products. Revenue from our global thrombectomy products increased $132.4 million, or 16.2%, to $947.9 million in 2025, from $815.5 million in 2024.
The increase was primarily due to a $34.3 million increase in personnel-related expenses driven by an increase in headcount and related expenses to support our growth, a $10.0 million increase in costs related to marketing events, and a $9.8 million increase in other professional services.
The increase was primarily due to a $74.5 million increase in personnel-related expenses driven by an increase in headcount and related expenses to support our growth, a $10.4 million increase in costs related to marketing events, and a $7.7 million increase in travel-related expenses.
The following table summarizes our cash and cash equivalents, marketable investments and selected working capital data as of December 31, 2024 and December 31, 2023: Year Ended December 31, 2024 2023 (in thousands) Cash and cash equivalents $ 324,404 $ 167,486 Marketable investments 15,727 121,701 Accounts receivable, net 167,668 201,768 Accounts payable 31,326 27,155 Accrued liabilities 112,429 110,555 Working capital (1) 792,780 764,258 (1) Working capital consists of total current assets less total current liabilities.
The following table summarizes our cash and cash equivalents, marketable investments and selected working capital data as of December 31, 2025 and December 31, 2024: Year Ended December 31, 2025 2024 (in thousands) Cash and cash equivalents $ 186,897 $ 324,404 Marketable investments 357,919 15,727 Accounts receivable, net 190,021 167,668 Accounts payable 34,736 31,326 Accrued liabilities 132,163 112,429 Working capital (1) 1,033,551 792,780 (1) Working capital consists of total current assets less total current liabilities.
For example, on February 14, 2025, the Company entered into agreements to acquire land in Costa Rica and construct a custom-built manufacturing facility and warehouse for the production of our products (refer to Note “20. Subsequent Events” to our consolidated financial statements in Part II, Item 8 of this Form 10-K for more information).
For example, during the year ended December 31, 2025, the Company entered into agreements to acquire property in Costa Rica and construct a manufacturing facility and warehouse for the production of medical devices. Refer to Note “5. Balance Sheet Components” to our consolidated financial statements in Part II, Item 8 of this Form 10-K for more information.
Liquidity and Capital Resources As of December 31, 2024, we had $792.8 million in working capital, which included $324.4 million in cash and cash equivalents and $15.7 million in marketable investments. As of December 31, 2024, we held approximately 7.9% of our cash and cash equivalents in foreign entities.
Liquidity and Capital Resources As of December 31, 2025, we had $1,033.6 million in working capital, which included $186.9 million in cash and cash equivalents and $357.9 million in marketable investments. As of December 31, 2025, we held approximately 11.3% of our cash and cash equivalents in foreign entities.
Revenue by Geographic Area The following table presents revenue by geographic area, based on our customers’ shipping destinations: Year Ended December 31, Change 2024 2023 $ % (in thousands, except for percentages) United States $ 902,067 75.5 % $ 757,151 71.5 % $ 144,916 19.1 % International 292,548 24.5 % 301,371 28.5 % (8,823) (2.9) % Total $ 1,194,615 100.0 % $ 1,058,522 100.0 % $ 136,093 12.9 % Revenue from sales in international markets decreased $8.8 million, or 2.9%, to $292.5 million in 2024, from $301.4 million in 2023.
Revenue by Geographic Area The following table presents revenue by geographic area, based on our customers’ shipping destinations: Year Ended December 31, Change 2025 2024 $ % (in thousands, except for percentages) United States $ 1,091,761 77.8 % $ 902,067 75.5 % $ 189,694 21.0 % International 311,904 22.2 % 292,548 24.5 % 19,356 6.6 % Total $ 1,403,665 100.0 % $ 1,194,615 100.0 % $ 209,050 17.5 % Revenue from sales in international markets increased $19.4 million, or 6.6%, to $311.9 million in 2025, from $292.5 million in 2024.
Management evaluates its estimates, assumptions and judgments on an ongoing basis. Historically, our critical accounting estimates have not differed materially from actual results. However, if our assumptions change, we may need to revise our estimates, or take other corrective actions, either of which may also have a material adverse effect on our consolidated statements of operations, liquidity and financial condition.
However, if our assumptions change, we may need to revise our estimates, or take other corrective actions, either of which may also have a material adverse effect on our consolidated statements of operations, liquidity and financial condition. 56 Table of Contents We believe the following critical accounting policies involve significant areas where management applies judgments and estimates in the preparation of our consolidated financial statements.
As of December 31, 2024, we measured our current DTA balances against estimates of future income based on objectively verifiable operating results from our recent history, and concluded that sufficient future taxable income will be generated to realize the benefits of our federal DTAs prior to expiration, including our federal research and development tax credit DTAs. 56 Table of Contents We continue to maintain a valuation allowance against our California tax credit DTAs until new evidence becomes available to justify realization of the asset.
As of December 31, 2025, we measured our current DTA balances against estimates of future income based on objectively verifiable operating results from our recent history, and concluded that sufficient future taxable income will be generated to realize the benefits of our federal DTAs.
Our research and development activities are centered around the development of new products and clinical activities designed to support our regulatory submissions and demonstrate the effectiveness of our products.
Generally, when we introduce a next generation product or a new product designed to replace a current product, sales of the earlier generation product or the product replaced decline. Our research and development activities are centered around the development of new products and clinical activities designed to support our regulatory submissions and demonstrate the effectiveness of our products.
As of December 31, 2024, the Company had remaining authority to purchase $100.0 million of its common stock under the share repurchase authorization. Refer to Note “12. Share Repurchase Program” to our consolidated financial statements in Part II, Item 8 of this Form 10-K for more information.
Refer to Note “12. Share Repurchase Program” to our consolidated financial statements in Part II, Item 8 of this Form 10-K for more information.
Summary of Significant Accounting Policies” to our consolidated financial statements in Part II, Item 8 of this Form 10-K. 65 Table of Contents
Commitments and Contingencies” to our consolidated financial statements in Part II, Item 8 of this Form 10-K. 58 Table of Contents Components of Results of Operations Revenue.
Commitments and Contingencies” to our consolidated financial statements in Part II, Item 8 of this Form 10-K. Components of Results of Operations Revenue. We sell our interventional products directly to hospitals and other healthcare providers and through distributors for use in procedures performed by specialist physicians to treat patients in two key markets: thrombectomy and embolization and access.
We sell our interventional products directly to hospitals and other healthcare providers and through distributors for use in procedures performed by specialist physicians to treat patients in two key markets: thrombectomy and embolization and access. We sell our products through purchase orders, and we do not have long term purchase commitments from our customers.
Asset Acquisition ” to our consolidated financial statements in Part II, Item 8 of this Form 10-K for more information. 61 Table of Contents Exit of Immersive Healthcare Business Year Ended December 31, Change 2024 2023 $ % (in thousands, except for percentages) Cost of revenue $ 33,362 $ — $ 33,362 100.0 % Impairment charge 76,945 — 76,945 100.0 % Severance and other associated costs 4,971 — 4,971 100.0 % Impact of Immersive Healthcare Business Exit $ 115,278 $ — $ 115,278 100.0 % Exit impact as a percentage of revenue 9.6 % — % During the year ended December 31, 2024, we made the strategic decision to wind down and exit our Immersive Healthcare business, and as a result we incurred $115.3 million in impairment and other charges in connection with this decision.
Exit of Immersive Healthcare Business Year Ended December 31, Change 2025 2024 $ % (in thousands, except for percentages) Cost of revenue $ — $ 33,362 $ (33,362) (100.0) % Impairment charge — 76,945 (76,945) (100.0) % Severance and other associated costs — 4,971 (4,971) (100.0) % Impact of Immersive Healthcare Business Exit $ — $ 115,278 $ (115,278) (100.0) % Exit impact as a percentage of revenue — % 9.6 % There were no impairment or other charges related to the immersive healthcare business during the year ended December 31, 2025.
Exit of Immersive Healthcare Business” to our consolidated financial statements in Part II, Item 8 of this Form 10-K for more information). This compares to gross margin of 64.5% in 2023. The impact of the $7.3 million Italian payback provision and one-time $33.4 million inventory charge decreased our gross margin by 3.0 percentage points in 2024.
This compares to gross margin of 63.2% in 2024, which included a one-time $33.4 million inventory charge to cost of revenue in connection with the impairment of our immersive healthcare asset group (refer to Note “4. Exit of Immersive Healthcare Business” to our consolidated financial statements in Part II, Item 8 of this Form 10-K for more information).
Provision for (benefit from) income taxes Year Ended December 31, Change 2024 2023 $ % (in thousands, except for percentages) Provision for (benefit from) income taxes $ 6,857 $ (11,304) $ 18,161 (160.7) % Effective tax rate 32.9 % (14.2) % Our provision for income taxes was $6.9 million in 2024, which was primarily due to income taxes imposed on our worldwide profits.
Provision for income taxes Year Ended December 31, Change 2025 2024 $ % (in thousands, except for percentages) Provision for income taxes $ 27,438 $ 6,857 $ 20,581 300.1 % Effective tax rate 13.4 % 32.9 % Our provision for income taxes was $27.4 million in 2025, which was primarily due to income taxes imposed on our worldwide profits, partially offset by excess tax benefits from stock-based compensation attributable to our U.S. jurisdiction.
Net cash used in operating activities was $55.7 million in 2022 and consisted of net loss of $2.0 million and net changes in operating assets and liabilities of $121.5 million offset by non-cash items of $67.9 million.
Net cash provided by operating activities was $238.7 million in 2025 and consisted of net income of $177.7 million and non-cash items of $103.7 million offset by net changes in operating assets and liabilities of $42.7 million.
We have successfully developed, obtained regulatory clearance or approval for, and introduced products into the thrombectomy market since 2007, access market since 2008, embolization market since 2011, and neurosurgical market since 2014, and operated in the immersive healthcare market from 2020 until September 2024.
We have successfully developed, obtained regulatory clearance or approval for, and introduced products into the thrombectomy market since 2007, access market since 2008, embolization market since 2011, and neurosurgical market since 2014. We expect to continue to develop and build our portfolio of products, including our thrombectomy, embolization, and access technologies, while iterating on our currently available products.
We sell our products through purchase orders, and we do not have long term purchase commitments from our customers. Revenue from product sales is recognized either on the date of shipment or the date of receipt by the customer, but is deferred for certain transactions when control has not yet transferred.
Revenue from product sales is recognized either on the date of shipment or the date of receipt by the customer, but is deferred for certain transactions when control has not yet transferred. With respect to products that we consign to hospitals, which primarily consist of coils, we recognize revenue at the time hospitals utilize products in a procedure.
Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuation allowance is established when it is more likely than not that the future realization of all or some of the DTAs will not be achieved.
Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized.
We acknowledge potential uncertainties in global implementation of Pillar Two, and will continue to monitor future tax legislation to determine their impact accordingly. Goodwill Goodwill represents the excess of the purchase price of an acquired business or assets over the fair value of the identifiable assets acquired and liabilities assumed.
Goodwill Goodwill represents the excess of the purchase price of an acquired business or assets over the fair value of the identifiable assets acquired and liabilities assumed.
Net cash provided by financing activities was $11.6 million in 2022 and primarily consisted of proceeds from the issuance of stock under our employee stock purchase plan of $13.8 million and proceeds from exercises of stock options of $7.8 million.
Net cash provided by financing activities was $26.5 million in 2025 and primarily consisted of proceeds from the issuance of common stock under our employee stock purchase plan of $16.4 million and proceeds from exercises of stock options of $15.4 million, partially offset by payments of employee taxes related to vested restricted stock units of $2.5 million and payments towards finance leases obligations of $2.5 million.
With respect to products that we consign to hospitals, which primarily consist of coils, we recognize revenue at the time hospitals utilize products in a procedure. Revenue also includes shipping and handling costs that we charge to customers. Cost of Revenue.
Revenue also includes shipping and handling costs that we charge to customers. Cost of Revenue.
This was partially offset by an increase in accounts payable of $13.4 million, an increase in accrued expenses and other non-current liabilities of $10.5 million primarily as a result of the growth in our business activities and proceeds of $0.3 million received related to lease incentives from operating leases.
This was partially offset by an increase in accrued expenses and other non-current liabilities of $12.9 million and an increase in accounts payable of $3.1 million.
Refer to Note “4. Exit of Immersive Healthcare Business” for more details. There was no impairment of long-lived assets during the years ended December 31, 2023, or 2022. Loss Contingencies We are subject to certain legal proceedings, as well as demands, claims and threatened litigation that arise in the normal course of our business.
Loss Contingencies We are subject to certain legal proceedings, as well as demands, claims and threatened litigation that arise in the normal course of our business. We review the status of each significant matter quarterly and assess our potential financial exposure.
Net cash provided by investing activities was $54.8 million in 2022 and primarily consisted of proceeds from maturities and sales of marketable investments of $74.1 million, partially offset by capital expenditures of $19.3 million.
Net cash used in investing activities was $404.6 million in 2025 and primarily consisted of purchases of marketable investments, net of proceeds from maturities and sales of marketable investments, of $340.9 million and capital expenditures of $63.7 million primarily driven by investments related to the construction of our Costa Rica manufacturing facility.
The increase was primarily due to a $3.3 million increase in product development and testing costs, $2.6 million in one-time expenses in connection with the wind down of the Immersive Healthcare business, and a $1.8 million increase in personnel-related expenses driven by an increase in headcount and related expenses to support our growth.
The decrease was primarily due to a $14.2 million decrease in expenses associated with our immersive healthcare business. Excluding these costs, R&D expenses increased by $9.2 million in 2025 to support our continued growth. We have continued to make investments, and plan to continue to make investments, in the development of our products.
The decrease in our global embolization and access products was primarily driven by our international embolization and access products, which decreased by 7.6% in the year ended December 31, 2024, partially offset by a 3.3% increase in sales of our U.S. embolization and access products. Prices for our embolization and access products remained substantially unchanged during the period.
The increase in our global embolization and access products was primarily attributable to higher sales volume in the United States as a result of sales of new products and further market penetration of our existing products. Sales of our U.S. embolization and access products increased by 25.4% in the year ended December 31, 2025.
Our effective tax rate was 32.9% in 2024, compared to (14.2)% in 2023. Our change in effective tax rate was primarily attributable to excess tax benefits from stock-based compensation and substantial tax benefits recorded from releasing the valuation allowance against federal research and development credits and partial California DTAs in 2023.
Our provision for income taxes was $6.9 million in 2024, which was primarily due to income taxes imposed on our worldwide profits. Our effective tax rate was 13.4% in 2025, compared to 32.9% in 2024. Our change in effective tax rate was primarily attributable to an increase in excess tax benefits from stock-based compensation.
Removed
We expect to continue to develop and build our portfolio of products, including our thrombectomy, embolization, and access technologies, while iterating on our currently available products. Generally, when we introduce a next generation product or a new product designed to replace a current product, sales of the earlier generation product or the product replaced decline.
Added
There were no impairment or other charges in connection with the wind down and exit of our immersive healthcare business during the year ended December 31, 2025.
Removed
We believe the following critical accounting policies involve significant areas where management applies judgments and estimates in the preparation of our consolidated financial statements. Revenue Recognition Revenue is primarily comprised of product revenue net of returns, discounts, administration fees and sales rebates.
Added
On January 14, 2026, we entered into the Merger Agreement with Boston Scientific Corporation and Merger Sub, pursuant to which Boston Scientific Corporation has agreed to acquire us in the Merger at an enterprise value of approximately $14.5 billion.
Removed
While various countries have adopted or are in the process of passing legislation to adopt it, the United States issued an executive order announcing opposition to adopt these rules in January 2025. We have evaluated the tax impact in relevant countries and concluded that there is no impact to our tax provision for the year ended December 31, 2024.
Added
Under the terms of the Merger Agreement, which has been approved by the board of directors of each of the Company and Boston Scientific Corporation, the transaction values each share of our common stock at $374 per share, with our stockholders having the right to elect, for each share of our common stock held by them, to receive $374 in cash or 3.8721 shares of Boston Scientific Corporation’s common stock (valued at $374 based on the volume weighted average price of Boston Scientific Corporation’s common stock over the 10 trading days ending January 13, 2026), subject to proration, so that the total 55 Table of Contents transaction consideration is paid approximately 73% in cash and approximately 27% in shares of Boston Scientific’s common stock.
Removed
Intangible Assets Indefinite-lived intangible assets are tested for impairment at least annually in the fourth quarter of each year, or more frequently if events or circumstances indicate that it is more likely than not that the asset is impaired.
Added
The Merger is expected to close by the end of 2026, subject to customary closing conditions, including approval by our stockholders and regulatory approvals. See Note “20. Subsequent Events” to our consolidated financial statements in Part II, Item 8 of this Form 10-K for more information.
Removed
In conducting the annual impairment test for its indefinite-lived intangible assets, we may first perform a qualitative assessment to determine whether it is more likely than not (i.e. greater than 50% likelihood) that an indefinite-lived intangible asset is impaired.
Added
Management evaluates its estimates, assumptions and judgments on an ongoing basis. Historically, our critical accounting estimates have not differed materially from actual results.
Removed
In accordance with the authoritative guidance, we may elect to bypass the qualitative assessment and proceed directly to the quantitative test to compare the fair value of the indefinite-lived intangible asset to the carrying amount.
Added
We continue to maintain a valuation allowance against our California tax credit DTAs until new evidence becomes available to justify realization of the asset.
Removed
If the fair value of the asset is less than the carrying amount, an impairment loss would be recognized in an amount equal to the difference between the carrying amount and the fair value.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

5 edited+0 added−0 removed4 unchanged
Biggest changeWhile our gross margin for the year ended December 31, 2024 was primarily impacted by a $7.3 million reduction in revenue resulting from the Italian government’s payback provision, a one-time $33.4 million inventory impairment charge to cost of revenue in connection with the impairment of our Immersive Healthcare asset group, product mix, regional mix, and production initiatives to support demand and create future efficiencies, changes in prices did not have a significant impact on our results of operations for any periods presented on our consolidated financial statements. 66 Table of Contents
Biggest changeWhile our gross margin for the year ended December 31, 2025 was primarily impacted by favorable product mix across our regions and productivity improvements, changes in prices did not have a significant impact on our results of operations for any periods presented on our consolidated financial statements. 66 Table of Contents
We operate in countries other than the United States, and, therefore, we are exposed to foreign currency risks. We bill most sales outside of the United States in local currencies, primarily in euros, with some sales being denominated in other currencies.
Foreign Exchange Risk Management. We operate in countries other than the United States, and, therefore, we are exposed to foreign currency risks. We bill most sales outside of the United States in local currencies, primarily in euros, with some sales being denominated in other currencies.
We utilize external investment managers who adhere to the guidelines of our investment policy. A hypothetical 100 basis point change in interest rates would not have a material impact on the value of our cash and cash equivalents or marketable investments. Foreign Exchange Risk Management.
We do not invest in financial instruments for trading or speculative purposes, nor do we use leveraged financial instruments. We utilize external investment managers who adhere to the guidelines of our investment policy. A hypothetical 100 basis point change in interest rates would not have a material impact on the value of our cash and cash equivalents or marketable investments.
We had cash and cash equivalents of $324.4 million as of December 31, 2024, which consisted of funds held in commercial paper, money market funds, U.S. treasury securities, and general checking and savings accounts. In addition, we had marketable investments of $15.7 million, which consisted primarily of U.S. treasury securities.
We had cash and cash equivalents of $186.9 million as of December 31, 2025, which consisted of funds held primarily in money market funds and general checking and savings accounts. In addition, we had marketable investments of $357.9 million, which consisted primarily of commercial paper and corporate bonds.
Our investment policy is focused on the preservation of capital and supporting our liquidity needs. Under the policy, we invest in highly rated securities, while limiting the amount of credit exposure to any one issuer other than the U.S. government. We do not invest in financial instruments for trading or speculative purposes, nor do we use leveraged financial instruments.
Our investments are focused on the preservation of capital and principal, supporting our liquidity needs, and longer-term planning to ensure a competitive rate of return. We invest in highly rated securities, while limiting the amount of credit exposure to any one issuer other than the U.S. government.

Other PEN 10-K year-over-year comparisons